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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-02648 | Registry Identifier | NCI Clinical Trial Reporting Program | |
| UG1CA189823 | U.S. NIH Grant/Contract | View source |
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Severe lack of accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase III trial studies how well dexamethasone works in reducing everolimus-induced oral stomatitis in patients with cancer. Dexamethasone may help to reduce the everolimus-induced oral stomatitis so as to improve quality of life in cancer patients.
PRIMARY OBJECTIVES:
I. To determine if the initiation of dexamethasone at the start of everolimus treatment prevents mTOR inhibitor-associated stomatitis (mIAS)-associated pain, compared to the initiation of placebo.
II. To determine if the initiation of dexamethasone at the start of everolimus treatment will be superior compared to the initiation of placebo in terms of the overall severity of mIAS-associated pain.
SECONDARY OBJECTIVES:
I. To utilize the same measurement method that was reported in the SWISH trial: A combination of a patient reported pain scale, data from a normalcy of diet questionnaire, and clinician grading of stomatitis to determine the incidence of > grade 2 mIAS.
II. To determine if the initiation of dexamethasone at the start of everolimus increases time to development of mouth pain using daily numerical analog scale patient-reported data collection.
III. To assess if quality of life is better when dexamethasone mouth rinse use starts at the same time as everolimus use versus at the time when mouth pain begins.
IV. To investigate if starting dexamethasone mouth rinse concurrent with starting everolimus improves patients' ability to adhere to everolimus therapy.
V. To compare dexamethasone prescription fill rates and timing between patients who received placebo versus study drug at the initiation of everolimus.
Trial Design:
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive everolimus orally (PO) once daily (QD) as standard of care and dexamethasone as mouthwash over 2 minutes 4 times per day (QID) for 8 weeks.
GROUP II: Patients receive everolimus PO QD as standard of care and placebo as mouthwash over 2 minutes QID for 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (dexamethasone) | Experimental | Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks. |
|
| Group II (placebo) | Placebo Comparator | Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Given as mouthwash |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale | The numerical analogue mouth pain score (NAMPS) is a single item measured on a 0 to 10 scale, with 0 corresponding to "No pain" and 10 corresponding to "Pain as bad as it can be." Will compare the incidence rate of any mouth pain (i.e., any score greater than 0) as assessed by the NAMPS between the prevention versus early treatment approaches using a Chi-square test. | Up to 8 weeks |
| Severity of Mouth Pain Scores | Average Area Under the Curve per assessment (aAUCpa) of mouth pain scores as measured by NAMPS will be computed for each patient to summarize the sequence of numerical analogue mouth pain scores over the eight week study period. Scores are reported on a 0-100 scale, where 100 = better outcome QOL (i.e. less pain). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the end of the treatment at 8 weeks post-treatment-initiation and will be compared between the two treatment arms. | Up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Grade > 2 mIAS as Measured by the SWISH Trial | Original plan for collecting and analyzing this data did not occur due to study termination. Grade 2 mIAS is defined as having at least one of the following criteria:>
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale by Sex | NIH-required analysis. The numerical analogue mouth pain score (NAMPS) is a single item measured on a 0 to 10 scale, with 0 corresponding to "No pain" and 10 corresponding to "Pain as bad as it can be." Will compare the incidence rate of any mouth pain (i.e., any score greater than 0) as assessed by the NAMPS between the prevention versus early treatment approaches using a Chi-square test. |
Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathryn Ruddy, MD | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | Birmingham | Alabama | 35233 | United States | ||
| Kingman Regional Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36693773 | Derived | Ruddy KJ, Zahrieh D, He J, Waechter B, Holleran JL, Lewis LD, Chow S, Beumer J, Weiss M, Trikalinos N, Faller B, Lustberg M, Rugo HS, Loprinzi C. Dexamethasone to prevent everolimus-induced stomatitis (Alliance MIST Trial: A221701). Semin Oncol. 2023 Feb-Apr;50(1-2):7-10. doi: 10.1053/j.seminoncol.2023.01.001. Epub 2023 Jan 17. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Individual Participant Data Set | View IPD |
Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive
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| ID | Title | Description |
|---|---|---|
| FG000 | Group I (Dexamethasone) | Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks. Dexamethasone: Given as mouthwash Questionnaire: Ancillary studies Quality-of-Life Assessment: Ancillary studies Everolimus: Standard of care |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 14, 2020 |
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| Other |
Given as mouthwash |
|
| Questionnaire | Other | Ancillary studies |
|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
| Everolimus | Drug | Standard of care |
|
| Up to 8 weeks |
| Incidence of Mouth Pain | Original plan for collecting and analyzing this data did not occur due to study termination. Will determine if the initiation of dexamethasone at the start of everolimus is associated with the incidence and of mild (score of 1-3), moderate (score of 4-6) and severe (score of 7-10) mouth pain as measured by the NAMPS. Will be assessed by Chi-square tests. | Up to 8 weeks |
| Time to Development of Mouth Pain | Original plan for collecting and analyzing this data did not occur due to study termination. Will determine if the initiation of dexamethasone at the start of everolimus is associated with the time to development of mild (score of 1-3), moderate (score of 4-6) and severe (score of 7-10) mouth pain as measured by the NAMPS. Will be assessed by Kaplan-Meier and cumulative incidence curves. | Up to 8 weeks |
| Quality of Life Assessed by Linear Analogue Self-Assessment | Original plan for collecting and analyzing this data did not occur due to study termination. Will determine if the initiation of dexamethasone at the start of everolimus is associated with quality of life is by comparing numerical analogue scale scores as measured by the Linear Analogue Self-Assessment. The Linear Analogue Self Assessment for quality of life is measured on a 0 to 10 scale, with 0 corresponding to "Quality of life as bad as it can be" and 10 corresponding to "Quality of life as good as it can be." Will be assessed by independent samples t-tests. | Up to 8 weeks |
| Mouth/Throat Sore Level of Activity Interference With Daily Activities | Original plan for collecting and analyzing this data did not occur due to study termination. Will determine if the initiation of dexamethasone at the start of everolimus is associated with the level of interference with daily activities as measured by the Patient Reported Outcome (PRO) Common Terminology criteria for Adverse Events (CTCAE) mouth/throat item regarding level of interference with daily activities. The PRO-CTCAE mouth/throat item regarding level of interference with daily activities is measured on a Likert 1-5 scale, with 1 corresponding to "Not at all" and 5 corresponding to "Very much." Will be assessed by independent samples t-tests. | Up to 8 weeks |
| Sleep Level of Activity Interference With Daily Activities | Original plan for collecting and analyzing this data did not occur due to study termination. Will determine if the initiation of dexamethasone at the start of everolimus is associated with the level of interference with daily activities as measured by the PRO-CTCAE sleep item regarding level of interference with daily activities. The PRO-CTCAE sleep item regarding level of interference with daily activities is measured on a Likert 1-5 scale, with 1 corresponding to "Not at all" and 5 corresponding to "Very much." Will be assessed by independent samples t-tests. | Up to 8 weeks |
| Adherence to Everolimus Therapy Dose | Original plan for collecting and analyzing this data did not occur due to study termination. Will compare mean daily dose of everolimus between the arms. The mean daily dose of everolimus over 8 weeks will be compared between study arms using independent samples t-tests. | Up to 8 weeks |
| Incidence of Patients Stopping Everolimus Early | Original plan for collecting and analyzing this data did not occur due to study termination. Will compare the number of patients who stopped everolimus early between the treatment arms. Will be compared using Chi-squared tests. | Up to 8 weeks |
| Incidence of Patients Reducing Everolimus Dose | Original plan for collecting and analyzing this data did not occur due to study termination. Will compare the number of patients who reduced their everolimus dose between the treatment arms. Will be compared using Chi-squared tests. | Up to 8 weeks |
| Dexamethasone Prescription Fill Rates | Original plan for collecting and analyzing this data did not occur due to study termination. Will compare dexamethasone prescription fill rates between the treatment groups. This will be compared using Chi-squared tests. | Up to 8 weeks |
| Time to Dexamethasone Prescription Fill | Original plan for collecting and analyzing this data did not occur due to study termination. Will compare the time to dexamethasone prescription fill between the treatment groups. This will be compared using Kaplan-Meier and cumulative incidence curves. | Up to 8 weeks |
| Time to Develop Mouth Sores Per Study Arm Assessed by PRO-CTCAE Mouth/Throat Sore Item Regarding Severity | Original plan for collecting and analyzing this data did not occur due to study termination. The time to develop at least mild, moderate, or severe (including "Very severe") mouth sores per study arm as measured by the PRO-CTCAE mouth-throat sore item regarding severity. The PRO-CTCAE mouth-throat sore item regarding severity is measured on a Likert 1-5 scale, with 1 corresponding to "None" and 5 corresponding to "Very severe". Will be assessed by Kaplan-Meier and cumulative incidence curves. | Up to 8 weeks |
| Mean Degrees of Patient-reported Mouth Sores Per Study Arm Assessed by NAMPS | Original plan for collecting and analyzing this data did not occur due to study termination. The mean degrees of patient-reported mouth sores per study arm as measured by the NAMPS will be assessed by independent samples t-tests. | Up to 8 weeks |
| Median Degree of Patient-reported Mouth Sores Per Study Arm Assessed by NAMPS | Original plan for collecting and analyzing this data did not occur due to study termination. The median degrees of patient-reported mouth sores per study arm as measured by the NAMPS will be assessed by independent samples t-tests. | Up to 8 weeks |
| Proportion of Patients Who Experience Grade 2 Stomatitis | Original plan for collecting and analyzing this data did not occur due to study termination. The proportion of patients who experience clinician-reported grade 2 stomatitis (as measured by the CTCAE and performed at 1 and 2 months post-baseline) per study arm will be assessed by Chi-squared tests. | Up to 2 months |
| Up to 8 weeks |
| Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale by Race | NIH-required analysis. The numerical analogue mouth pain score (NAMPS) is a single item measured on a 0 to 10 scale, with 0 corresponding to "No pain" and 10 corresponding to "Pain as bad as it can be." Will compare the incidence rate of any mouth pain (i.e., any score greater than 0) as assessed by the NAMPS between the prevention versus early treatment approaches using a Chi-square test. | Up to 8 weeks |
| Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale by Ethnicity. | NIH-required analysis. The numerical analogue mouth pain score (NAMPS) is a single item measured on a 0 to 10 scale, with 0 corresponding to "No pain" and 10 corresponding to "Pain as bad as it can be." Will compare the incidence rate of any mouth pain (i.e., any score greater than 0) as assessed by the NAMPS between the prevention versus early treatment approaches using a Chi-square test. | Up to 8 weeks |
| Severity of Mouth Pain Scores by Sex | Average Area Under the Curve per assessment (aAUCpa) of mouth pain scores as measured by NAMPS will be computed for each patient to summarize the sequence of numerical analogue mouth pain scores over the eight week study period. Scores are reported on a 0-100 scale, where 100 = better outcome QOL (i.e. less pain). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the end of the treatment at 8 weeks post-treatment-initiation and will be compared between the two treatment arms. | Up to 8 weeks |
| Severity of Mouth Pain Scores by Race | Average Area Under the Curve per assessment (aAUCpa) of mouth pain scores as measured by NAMPS will be computed for each patient to summarize the sequence of numerical analogue mouth pain scores over the eight week study period. Scores are reported on a 0-100 scale, where 100 = better outcome QOL (i.e. less pain). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the end of the treatment at 8 weeks post-treatment-initiation and will be compared between the two treatment arms. | Up to 8 weeks |
| Severity of Mouth Pain Scores by Ethnicity | Average Area Under the Curve per assessment (aAUCpa) of mouth pain scores as measured by NAMPS will be computed for each patient to summarize the sequence of numerical analogue mouth pain scores over the eight week study period. Scores are reported on a 0-100 scale, where 100 = better outcome QOL (i.e. less pain). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the end of the treatment at 8 weeks post-treatment-initiation and will be compared between the two treatment arms. | Up to 8 weeks |
| Kingman |
| Arizona |
| 86401 |
| United States |
| Mercy Hospital Fort Smith | Fort Smith | Arkansas | 72903 | United States |
| PCR Oncology | Arroyo Grande | California | 93420 | United States |
| Epic Care-Dublin | Dublin | California | 94568 | United States |
| Bay Area Breast Surgeons Inc | Emeryville | California | 94608 | United States |
| Epic Care Partners in Cancer Care | Emeryville | California | 94608 | United States |
| Contra Costa Regional Medical Center | Martinez | California | 94553-3156 | United States |
| Alta Bates Summit Medical Center - Summit Campus | Oakland | California | 94609 | United States |
| Bay Area Tumor Institute | Oakland | California | 94609 | United States |
| Epic Care Cyberknife Center | Walnut Creek | California | 94597 | United States |
| Holy Cross Hospital | Fort Lauderdale | Florida | 33308 | United States |
| Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho | 83706 | United States |
| Saint Alphonsus Cancer Care Center-Caldwell | Caldwell | Idaho | 83605 | United States |
| Kootenai Medical Center | Coeur d'Alene | Idaho | 83814 | United States |
| Walter Knox Memorial Hospital | Emmett | Idaho | 83617 | United States |
| Idaho Urologic Institute-Meridian | Meridian | Idaho | 83642 | United States |
| Saint Alphonsus Medical Center-Nampa | Nampa | Idaho | 83686 | United States |
| Kootenai Cancer Center | Post Falls | Idaho | 83854 | United States |
| Kootenai Cancer Clinic | Sandpoint | Idaho | 83864 | United States |
| Rush - Copley Medical Center | Aurora | Illinois | 60504 | United States |
| Illinois CancerCare-Bloomington | Bloomington | Illinois | 61704 | United States |
| Illinois CancerCare-Canton | Canton | Illinois | 61520 | United States |
| Memorial Hospital of Carbondale | Carbondale | Illinois | 62902 | United States |
| SIH Cancer Institute | Carterville | Illinois | 62918 | United States |
| Illinois CancerCare-Carthage | Carthage | Illinois | 62321 | United States |
| Centralia Oncology Clinic | Centralia | Illinois | 62801 | United States |
| Carle on Vermilion | Danville | Illinois | 61832 | United States |
| Cancer Care Specialists of Illinois - Decatur | Decatur | Illinois | 62526 | United States |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | United States |
| Illinois CancerCare-Dixon | Dixon | Illinois | 61021 | United States |
| Carle Physician Group-Effingham | Effingham | Illinois | 62401 | United States |
| Crossroads Cancer Center | Effingham | Illinois | 62401 | United States |
| Illinois CancerCare-Eureka | Eureka | Illinois | 61530 | United States |
| Illinois CancerCare-Galesburg | Galesburg | Illinois | 61401 | United States |
| Western Illinois Cancer Treatment Center | Galesburg | Illinois | 61401 | United States |
| Illinois CancerCare-Kewanee Clinic | Kewanee | Illinois | 61443 | United States |
| Illinois CancerCare-Macomb | Macomb | Illinois | 61455 | United States |
| Carle Physician Group-Mattoon/Charleston | Mattoon | Illinois | 61938 | United States |
| Good Samaritan Regional Health Center | Mount Vernon | Illinois | 62864 | United States |
| Cancer Care Center of O'Fallon | O'Fallon | Illinois | 62269 | United States |
| Illinois CancerCare-Ottawa Clinic | Ottawa | Illinois | 61350 | United States |
| Illinois CancerCare-Pekin | Pekin | Illinois | 61554 | United States |
| Illinois CancerCare-Peoria | Peoria | Illinois | 61615 | United States |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61636 | United States |
| Illinois CancerCare-Peru | Peru | Illinois | 61354 | United States |
| Valley Radiation Oncology | Peru | Illinois | 61354 | United States |
| Illinois CancerCare-Princeton | Princeton | Illinois | 61356 | United States |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62702 | United States |
| Springfield Clinic | Springfield | Illinois | 62702 | United States |
| Memorial Medical Center | Springfield | Illinois | 62781 | United States |
| Southwest Illinois Health Services LLP | Swansea | Illinois | 62226 | United States |
| Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| The Carle Foundation Hospital | Urbana | Illinois | 61801 | United States |
| Rush-Copley Healthcare Center | Yorkville | Illinois | 60560 | United States |
| Physicians' Clinic of Iowa PC | Cedar Rapids | Iowa | 52402 | United States |
| Iowa Methodist Medical Center | Des Moines | Iowa | 50309 | United States |
| Medical Oncology and Hematology Associates-Des Moines | Des Moines | Iowa | 50309 | United States |
| Broadlawns Medical Center | Des Moines | Iowa | 50314 | United States |
| Iowa Lutheran Hospital | Des Moines | Iowa | 50316 | United States |
| Trinity Regional Medical Center | Fort Dodge | Iowa | 50501 | United States |
| Methodist West Hospital | West Des Moines | Iowa | 50266-7700 | United States |
| Ochsner LSU Health Monroe Medical Center | Monroe | Louisiana | 71202 | United States |
| LSU Health Sciences Center at Shreveport | Shreveport | Louisiana | 71103 | United States |
| Lafayette Family Cancer Center-EMMC | Brewer | Maine | 04412 | United States |
| Mercy Medical Center | Springfield | Massachusetts | 01104 | United States |
| Saint Joseph Mercy Hospital | Ann Arbor | Michigan | 48106 | United States |
| Bronson Battle Creek | Battle Creek | Michigan | 49017 | United States |
| IHA Hematology Oncology Consultants-Brighton | Brighton | Michigan | 48114 | United States |
| Saint Joseph Mercy Brighton | Brighton | Michigan | 48114 | United States |
| IHA Hematology Oncology Consultants-Canton | Canton | Michigan | 48188 | United States |
| Saint Joseph Mercy Canton | Canton | Michigan | 48188 | United States |
| Caro Cancer Center | Caro | Michigan | 48723 | United States |
| IHA Hematology Oncology Consultants-Chelsea | Chelsea | Michigan | 48118 | United States |
| Saint Joseph Mercy Chelsea | Chelsea | Michigan | 48118 | United States |
| Hematology Oncology Consultants-Clarkston | Clarkston | Michigan | 48346 | United States |
| Newland Medical Associates-Clarkston | Clarkston | Michigan | 48346 | United States |
| Ascension Saint John Hospital | Detroit | Michigan | 48236 | United States |
| Great Lakes Cancer Management Specialists-Doctors Park | East China Township | Michigan | 48054 | United States |
| Genesee Cancer and Blood Disease Treatment Center | Flint | Michigan | 48503 | United States |
| Genesee Hematology Oncology PC | Flint | Michigan | 48503 | United States |
| Genesys Hurley Cancer Institute | Flint | Michigan | 48503 | United States |
| Hurley Medical Center | Flint | Michigan | 48503 | United States |
| Helen DeVos Children's Hospital at Spectrum Health | Grand Rapids | Michigan | 49503 | United States |
| Mercy Health Saint Mary's | Grand Rapids | Michigan | 49503 | United States |
| Spectrum Health at Butterworth Campus | Grand Rapids | Michigan | 49503 | United States |
| Academic Hematology Oncology Specialists | Grosse Pointe Woods | Michigan | 48236 | United States |
| Great Lakes Cancer Management Specialists-Van Elslander Cancer Center | Grosse Pointe Woods | Michigan | 48236 | United States |
| Michigan Breast Specialists-Grosse Pointe Woods | Grosse Pointe Woods | Michigan | 48236 | United States |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | United States |
| Borgess Medical Center | Kalamazoo | Michigan | 49048 | United States |
| Sparrow Hospital | Lansing | Michigan | 48912 | United States |
| Hope Cancer Clinic | Livonia | Michigan | 48154 | United States |
| Saint Mary Mercy Hospital | Livonia | Michigan | 48154 | United States |
| Great Lakes Cancer Management Specialists-Macomb Medical Campus | Macomb | Michigan | 48044 | United States |
| Michigan Breast Specialists-Macomb Township | Macomb | Michigan | 48044 | United States |
| Saint Mary's Oncology/Hematology Associates of Marlette | Marlette | Michigan | 48453 | United States |
| Mercy Health Mercy Campus | Muskegon | Michigan | 49444 | United States |
| Lakeland Hospital Niles | Niles | Michigan | 49120 | United States |
| Cancer and Hematology Centers of Western Michigan - Norton Shores | Norton Shores | Michigan | 49444 | United States |
| 21st Century Oncology-Pontiac | Pontiac | Michigan | 48341 | United States |
| Hope Cancer Center | Pontiac | Michigan | 48341 | United States |
| Newland Medical Associates-Pontiac | Pontiac | Michigan | 48341 | United States |
| Saint Joseph Mercy Oakland | Pontiac | Michigan | 48341 | United States |
| Huron Medical Center PC | Port Huron | Michigan | 48060 | United States |
| Lake Huron Medical Center | Port Huron | Michigan | 48060 | United States |
| Spectrum Health Reed City Hospital | Reed City | Michigan | 49677 | United States |
| Great Lakes Cancer Management Specialists-Rochester Hills | Rochester Hills | Michigan | 48309 | United States |
| Ascension Saint Mary's Hospital | Saginaw | Michigan | 48601 | United States |
| Oncology Hematology Associates of Saginaw Valley PC | Saginaw | Michigan | 48604 | United States |
| Lakeland Medical Center Saint Joseph | Saint Joseph | Michigan | 49085 | United States |
| Marie Yeager Cancer Center | Saint Joseph | Michigan | 49085 | United States |
| Bhadresh Nayak MD PC-Sterling Heights | Sterling Heights | Michigan | 48312 | United States |
| Ascension Saint Joseph Hospital | Tawas City | Michigan | 48764 | United States |
| Munson Medical Center | Traverse City | Michigan | 49684 | United States |
| Advanced Breast Care Center PLLC | Warren | Michigan | 48088 | United States |
| Great Lakes Cancer Management Specialists-Macomb Professional Building | Warren | Michigan | 48093 | United States |
| Macomb Hematology Oncology PC | Warren | Michigan | 48093 | United States |
| Michigan Breast Specialists-Warren | Warren | Michigan | 48093 | United States |
| Saint John Macomb-Oakland Hospital | Warren | Michigan | 48093 | United States |
| Saint Mary's Oncology/Hematology Associates of West Branch | West Branch | Michigan | 48661 | United States |
| Metro Health Hospital | Wyoming | Michigan | 49519 | United States |
| Huron Gastroenterology PC | Ypsilanti | Michigan | 48106 | United States |
| IHA Hematology Oncology Consultants-Ann Arbor | Ypsilanti | Michigan | 48197 | United States |
| Sanford Joe Lueken Cancer Center | Bemidji | Minnesota | 56601 | United States |
| Fairview Ridges Hospital | Burnsville | Minnesota | 55337 | United States |
| Cambridge Medical Center | Cambridge | Minnesota | 55008 | United States |
| Mercy Hospital | Coon Rapids | Minnesota | 55433 | United States |
| Fairview Southdale Hospital | Edina | Minnesota | 55435 | United States |
| Unity Hospital | Fridley | Minnesota | 55432 | United States |
| Fairview Clinics and Surgery Center Maple Grove | Maple Grove | Minnesota | 55369 | United States |
| Minnesota Oncology Hematology PA-Maplewood | Maplewood | Minnesota | 55109 | United States |
| Saint John's Hospital - Healtheast | Maplewood | Minnesota | 55109 | United States |
| Abbott-Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
| Health Partners Inc | Minneapolis | Minnesota | 55454 | United States |
| Monticello Cancer Center | Monticello | Minnesota | 55362 | United States |
| New Ulm Medical Center | New Ulm | Minnesota | 56073 | United States |
| Fairview Northland Medical Center | Princeton | Minnesota | 55371 | United States |
| North Memorial Medical Health Center | Robbinsdale | Minnesota | 55422 | United States |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota | 55416 | United States |
| Regions Hospital | Saint Paul | Minnesota | 55101 | United States |
| United Hospital | Saint Paul | Minnesota | 55102 | United States |
| Saint Francis Regional Medical Center | Shakopee | Minnesota | 55379 | United States |
| Lakeview Hospital | Stillwater | Minnesota | 55082 | United States |
| Sanford Thief River Falls Medical Center | Thief River Falls | Minnesota | 56701 | United States |
| Ridgeview Medical Center | Waconia | Minnesota | 55387 | United States |
| Rice Memorial Hospital | Willmar | Minnesota | 56201 | United States |
| Minnesota Oncology Hematology PA-Woodbury | Woodbury | Minnesota | 55125 | United States |
| Sanford Cancer Center Worthington | Worthington | Minnesota | 56187 | United States |
| Fairview Lakes Medical Center | Wyoming | Minnesota | 55092 | United States |
| Saint Louis Cancer and Breast Institute-Ballwin | Ballwin | Missouri | 63011 | United States |
| Parkland Health Center-Bonne Terre | Bonne Terre | Missouri | 63628 | United States |
| Cox Cancer Center Branson | Branson | Missouri | 65616 | United States |
| Saint Francis Medical Center | Cape Girardeau | Missouri | 63703 | United States |
| Southeast Cancer Center | Cape Girardeau | Missouri | 63703 | United States |
| Siteman Cancer Center at Saint Peters Hospital | City of Saint Peters | Missouri | 63376 | United States |
| Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri | 63141 | United States |
| Parkland Health Center - Farmington | Farmington | Missouri | 63640 | United States |
| Capital Region Southwest Campus | Jefferson City | Missouri | 65109 | United States |
| Freeman Health System | Joplin | Missouri | 64804 | United States |
| Mercy Hospital Joplin | Joplin | Missouri | 64804 | United States |
| Delbert Day Cancer Institute at PCRMC | Rolla | Missouri | 65401 | United States |
| Mercy Clinic-Rolla-Cancer and Hematology | Rolla | Missouri | 65401 | United States |
| Heartland Regional Medical Center | Saint Joseph | Missouri | 64506 | United States |
| Sainte Genevieve County Memorial Hospital | Sainte Genevieve | Missouri | 63670 | United States |
| Mercy Hospital Springfield | Springfield | Missouri | 65804 | United States |
| CoxHealth South Hospital | Springfield | Missouri | 65807 | United States |
| Saint Louis Cancer and Breast Institute-South City | St Louis | Missouri | 63109 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Mercy Hospital South | St Louis | Missouri | 63128 | United States |
| Siteman Cancer Center-South County | St Louis | Missouri | 63129 | United States |
| Missouri Baptist Medical Center | St Louis | Missouri | 63131 | United States |
| Siteman Cancer Center at Christian Hospital | St Louis | Missouri | 63136 | United States |
| Mercy Hospital Saint Louis | St Louis | Missouri | 63141 | United States |
| Missouri Baptist Sullivan Hospital | Sullivan | Missouri | 63080 | United States |
| Missouri Baptist Outpatient Center-Sunset Hills | Sunset Hills | Missouri | 63127 | United States |
| Mercy Hospital Washington | Washington | Missouri | 63090 | United States |
| Community Hospital of Anaconda | Anaconda | Montana | 59711 | United States |
| Billings Clinic Cancer Center | Billings | Montana | 59101 | United States |
| Bozeman Deaconess Hospital | Bozeman | Montana | 59715 | United States |
| Benefis Healthcare- Sletten Cancer Institute | Great Falls | Montana | 59405 | United States |
| Great Falls Clinic | Great Falls | Montana | 59405 | United States |
| Saint Peter's Community Hospital | Helena | Montana | 59601 | United States |
| Kalispell Regional Medical Center | Kalispell | Montana | 59901 | United States |
| Community Medical Hospital | Missoula | Montana | 59804 | United States |
| Nebraska Hematology and Oncology | Lincoln | Nebraska | 68506 | United States |
| Southeast Nebraska Cancer Center - 68th Street Place | Lincoln | Nebraska | 68516 | United States |
| Faith Regional Health Services Carson Cancer Center | Norfolk | Nebraska | 68701 | United States |
| Great Plains Health Callahan Cancer Center | North Platte | Nebraska | 69101 | United States |
| Nebraska Cancer Specialists - Omaha | Omaha | Nebraska | 68124 | United States |
| Oncology Hematology West PC | Omaha | Nebraska | 68130 | United States |
| Regional West Medical Center Cancer Center | Scottsbluff | Nebraska | 69361 | United States |
| Carson Tahoe Regional Medical Center | Carson City | Nevada | 89703 | United States |
| Cancer and Blood Specialists-Henderson | Henderson | Nevada | 89052 | United States |
| Comprehensive Cancer Centers of Nevada - Henderson | Henderson | Nevada | 89052 | United States |
| Comprehensive Cancer Centers of Nevada-Horizon Ridge | Henderson | Nevada | 89052 | United States |
| Las Vegas Cancer Center-Henderson | Henderson | Nevada | 89052 | United States |
| OptumCare Cancer Care at Seven Hills | Henderson | Nevada | 89052 | United States |
| 21st Century Oncology-Henderson | Henderson | Nevada | 89074 | United States |
| Comprehensive Cancer Centers of Nevada-Southeast Henderson | Henderson | Nevada | 89074 | United States |
| Las Vegas Urology - Green Valley | Henderson | Nevada | 89074 | United States |
| Las Vegas Urology - Pebble | Henderson | Nevada | 89074 | United States |
| Urology Specialists of Nevada - Green Valley | Henderson | Nevada | 89074 | United States |
| Las Vegas Urology - Pecos | Las Vegas | Nevada | 89074 | United States |
| Desert West Surgery | Las Vegas | Nevada | 89102 | United States |
| OptumCare Cancer Care at Oakey | Las Vegas | Nevada | 89102 | United States |
| University Medical Center of Southern Nevada | Las Vegas | Nevada | 89102 | United States |
| Hope Cancer Care of Nevada | Las Vegas | Nevada | 89103 | United States |
| Cancer and Blood Specialists-Shadow | Las Vegas | Nevada | 89106 | United States |
| Radiation Oncology Centers of Nevada Central | Las Vegas | Nevada | 89106 | United States |
| Urology Specialists of Nevada - Central | Las Vegas | Nevada | 89106 | United States |
| 21st Century Oncology | Las Vegas | Nevada | 89109 | United States |
| HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway | Las Vegas | Nevada | 89109 | United States |
| Sunrise Hospital and Medical Center | Las Vegas | Nevada | 89109 | United States |
| HealthCare Partners Medical Group Oncology/Hematology-San Martin | Las Vegas | Nevada | 89113 | United States |
| Las Vegas Prostate Cancer Center | Las Vegas | Nevada | 89113 | United States |
| Las Vegas Urology - Sunset | Las Vegas | Nevada | 89113 | United States |
| Radiation Oncology Centers of Nevada Southeast | Las Vegas | Nevada | 89119 | United States |
| 21st Century Oncology-Vegas Tenaya | Las Vegas | Nevada | 89128 | United States |
| Ann M Wierman MD LTD | Las Vegas | Nevada | 89128 | United States |
| Cancer and Blood Specialists-Tenaya | Las Vegas | Nevada | 89128 | United States |
| Comprehensive Cancer Centers of Nevada - Northwest | Las Vegas | Nevada | 89128 | United States |
| HealthCare Partners Medical Group Oncology/Hematology-Tenaya | Las Vegas | Nevada | 89128 | United States |
| Las Vegas Urology - Cathedral Rock | Las Vegas | Nevada | 89128 | United States |
| Las Vegas Urology - Smoke Ranch | Las Vegas | Nevada | 89128 | United States |
| OptumCare Cancer Care at MountainView | Las Vegas | Nevada | 89128 | United States |
| Urology Specialists of Nevada - Northwest | Las Vegas | Nevada | 89128 | United States |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation | Las Vegas | Nevada | 89135 | United States |
| Comprehensive Cancer Centers of Nevada - Town Center | Las Vegas | Nevada | 89144 | United States |
| Comprehensive Cancer Centers of Nevada-Summerlin | Las Vegas | Nevada | 89144 | United States |
| Summerlin Hospital Medical Center | Las Vegas | Nevada | 89144 | United States |
| Las Vegas Cancer Center-Medical Center | Las Vegas | Nevada | 89148-2405 | United States |
| 21st Century Oncology-Fort Apache | Las Vegas | Nevada | 89148 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89148 | United States |
| OptumCare Cancer Care at Fort Apache | Las Vegas | Nevada | 89148 | United States |
| Urology Specialists of Nevada - Southwest | Las Vegas | Nevada | 89148 | United States |
| HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills | Las Vegas | Nevada | 89149 | United States |
| Comprehensive Cancer Centers of Nevada - Central Valley | Las Vegas | Nevada | 89169 | United States |
| University Cancer Center | Las Vegas | Nevada | 89169 | United States |
| Hope Cancer Care of Nevada-Pahrump | Pahrump | Nevada | 89048 | United States |
| Renown Regional Medical Center | Reno | Nevada | 89502 | United States |
| Saint Mary's Regional Medical Center | Reno | Nevada | 89503 | United States |
| Radiation Oncology Associates | Reno | Nevada | 89509 | United States |
| New Hampshire Oncology Hematology PA-Concord | Concord | New Hampshire | 03301 | United States |
| Solinsky Center for Cancer Care | Manchester | New Hampshire | 03103 | United States |
| Virtua Samson Cancer Center | Moorestown | New Jersey | 08057 | United States |
| Virtua Memorial | Mount Holly | New Jersey | 08060 | United States |
| Virtua Voorhees | Voorhees Township | New Jersey | 08043 | United States |
| Hematology Oncology Associates of Central New York-Auburn | Auburn | New York | 13021 | United States |
| Hematology Oncology Associates of Central New York-East Syracuse | East Syracuse | New York | 13057 | United States |
| Hematology Oncology Associates of Central New York-Onondaga Hill | Syracuse | New York | 13215 | United States |
| CaroMont Regional Medical Center | Gastonia | North Carolina | 28054 | United States |
| Sanford Bismarck Medical Center | Bismarck | North Dakota | 58501 | United States |
| Sanford South University Medical Center | Fargo | North Dakota | 58103 | United States |
| Southpointe-Sanford Medical Center Fargo | Fargo | North Dakota | 58103 | United States |
| Sanford Medical Center Fargo | Fargo | North Dakota | 58104 | United States |
| Sanford Broadway Medical Center | Fargo | North Dakota | 58122 | United States |
| Sanford Roger Maris Cancer Center | Fargo | North Dakota | 58122 | United States |
| Altru Cancer Center | Grand Forks | North Dakota | 58201 | United States |
| Strecker Cancer Center-Belpre | Belpre | Ohio | 45714 | United States |
| Adena Regional Medical Center | Chillicothe | Ohio | 45601 | United States |
| Mount Carmel East Hospital | Columbus | Ohio | 43213 | United States |
| Columbus Oncology and Hematology Associates Inc | Columbus | Ohio | 43214 | United States |
| Riverside Methodist Hospital | Columbus | Ohio | 43214 | United States |
| Grant Medical Center | Columbus | Ohio | 43215 | United States |
| The Mark H Zangmeister Center | Columbus | Ohio | 43219 | United States |
| Mount Carmel Health Center West | Columbus | Ohio | 43222 | United States |
| Doctors Hospital | Columbus | Ohio | 43228 | United States |
| Delaware Health Center-Grady Cancer Center | Delaware | Ohio | 43015 | United States |
| Grady Memorial Hospital | Delaware | Ohio | 43015 | United States |
| Dublin Methodist Hospital | Dublin | Ohio | 43016 | United States |
| Central Ohio Breast and Endocrine Surgery | Gahanna | Ohio | 43230 | United States |
| Mount Carmel Grove City Hospital | Grove City | Ohio | 43123 | United States |
| Fairfield Medical Center | Lancaster | Ohio | 43130 | United States |
| OhioHealth Mansfield Hospital | Mansfield | Ohio | 44903 | United States |
| Marietta Memorial Hospital | Marietta | Ohio | 45750 | United States |
| OhioHealth Marion General Hospital | Marion | Ohio | 43302 | United States |
| Knox Community Hospital | Mount Vernon | Ohio | 43050 | United States |
| Licking Memorial Hospital | Newark | Ohio | 43055 | United States |
| Newark Radiation Oncology | Newark | Ohio | 43055 | United States |
| Southern Ohio Medical Center | Portsmouth | Ohio | 45662 | United States |
| Saint Ann's Hospital | Westerville | Ohio | 43081 | United States |
| Genesis Healthcare System Cancer Care Center | Zanesville | Ohio | 43701 | United States |
| Mercy Hospital Oklahoma City | Oklahoma City | Oklahoma | 73120 | United States |
| Saint Alphonsus Medical Center-Baker City | Baker City | Oregon | 97814 | United States |
| Legacy Mount Hood Medical Center | Gresham | Oregon | 97030 | United States |
| Saint Alphonsus Medical Center-Ontario | Ontario | Oregon | 97914 | United States |
| Legacy Good Samaritan Hospital and Medical Center | Portland | Oregon | 97210 | United States |
| Legacy Meridian Park Hospital | Tualatin | Oregon | 97062 | United States |
| Lehigh Valley Hospital-Cedar Crest | Allentown | Pennsylvania | 18103 | United States |
| Lehigh Valley Hospital - Muhlenberg | Bethlehem | Pennsylvania | 18017 | United States |
| Pocono Medical Center | East Stroudsburg | Pennsylvania | 18301 | United States |
| Lehigh Valley Hospital-Hazleton | Hazleton | Pennsylvania | 18201 | United States |
| Self Regional Healthcare | Greenwood | South Carolina | 29646 | United States |
| Sanford Cancer Center Oncology Clinic | Sioux Falls | South Dakota | 57104 | United States |
| Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | 57117-5134 | United States |
| Overlake Medical Center | Bellevue | Washington | 98004 | United States |
| Valley Medical Center | Renton | Washington | 98055 | United States |
| Legacy Cancer Institute Medical Oncology and Day Treatment | Vancouver | Washington | 98684 | United States |
| Legacy Salmon Creek Hospital | Vancouver | Washington | 98686 | United States |
| Marshfield Clinic-Chippewa Center | Chippewa Falls | Wisconsin | 54729 | United States |
| Marshfield Medical Center-EC Cancer Center | Eau Claire | Wisconsin | 54701 | United States |
| Mayo Clinic Health System-Eau Claire Clinic | Eau Claire | Wisconsin | 54701 | United States |
| Mayo Clinic Health System Eau Claire Hospital-Luther Campus | Eau Claire | Wisconsin | 54703 | United States |
| Mayo Clinic Health System-Franciscan Healthcare | La Crosse | Wisconsin | 54601 | United States |
| Marshfield Clinic - Ladysmith Center | Ladysmith | Wisconsin | 54848 | United States |
| Marshfield Medical Center-Marshfield | Marshfield | Wisconsin | 54449 | United States |
| Marshfield Clinic-Minocqua Center | Minocqua | Wisconsin | 54548 | United States |
| Cancer Center of Western Wisconsin | New Richmond | Wisconsin | 54017 | United States |
| Marshfield Medical Center-Rice Lake | Rice Lake | Wisconsin | 54868 | United States |
| Marshfield Clinic Stevens Point Center | Stevens Point | Wisconsin | 54482 | United States |
| Marshfield Clinic-Wausau Center | Wausau | Wisconsin | 54401 | United States |
| Marshfield Clinic - Weston Center | Weston | Wisconsin | 54476 | United States |
| Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids | Wisconsin | 54494 | United States |
| Billings Clinic-Cody | Cody | Wyoming | 82414 | United States |
| Welch Cancer Center | Sheridan | Wyoming | 82801 | United States |
Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive |
| Group II (Placebo) |
Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks. Placebo: Given as mouthwash Questionnaire: Ancillary studies Quality-of-Life Assessment: Ancillary studies Everolimus: Standard of care |
| COMPLETED |
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| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group I (Dexamethasone) | Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks. Dexamethasone: Given as mouthwash Questionnaire: Ancillary studies Quality-of-Life Assessment: Ancillary studies Everolimus: Standard of care |
| BG001 | Group II (Placebo) | Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks. Placebo: Given as mouthwash Questionnaire: Ancillary studies Quality-of-Life Assessment: Ancillary studies Everolimus: Standard of care |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Cancer Type | Count of Participants | Participants |
| ||||||||||||||||
| ECOG Performance Status | ECOG = 0: Fully active, able to carry on all pre-disease performance without restriction. ECOG = 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. ECOG = 2: Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours. ECOG = 0 is better. ECOG = 2 is worse. | Count of Participants | Participants |
| |||||||||||||||
| Continuous Patient Reported Mouth-Pain Score | Pain scale from 1-10. 1 is better and 10 is worse. | Mean | Standard Deviation | scores on a scale |
| ||||||||||||||
| Discrete Patient Reported Mouth-Pain Score | Mouth-Pain score = 0: Patient has no pain in their mouth. Mouth-Pain score > 0: Patient has pain in their mouth. Mouth-Pain score = 0 is better. Mouth-Pain score > 0 is worse. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale | The numerical analogue mouth pain score (NAMPS) is a single item measured on a 0 to 10 scale, with 0 corresponding to "No pain" and 10 corresponding to "Pain as bad as it can be." Will compare the incidence rate of any mouth pain (i.e., any score greater than 0) as assessed by the NAMPS between the prevention versus early treatment approaches using a Chi-square test. | Posted | Count of Participants | Participants | Up to 8 weeks |
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| Primary | Severity of Mouth Pain Scores | Average Area Under the Curve per assessment (aAUCpa) of mouth pain scores as measured by NAMPS will be computed for each patient to summarize the sequence of numerical analogue mouth pain scores over the eight week study period. Scores are reported on a 0-100 scale, where 100 = better outcome QOL (i.e. less pain). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the end of the treatment at 8 weeks post-treatment-initiation and will be compared between the two treatment arms. | Posted | Mean | Standard Deviation | scores on scale * days | Up to 8 weeks |
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| Secondary | Incidence of Grade > 2 mIAS as Measured by the SWISH Trial | Original plan for collecting and analyzing this data did not occur due to study termination. Grade 2 mIAS is defined as having at least one of the following criteria:>
| Original plan for collecting and analyzing this data did not occur due to study termination. | Posted | Up to 8 weeks |
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| Secondary | Incidence of Mouth Pain | Original plan for collecting and analyzing this data did not occur due to study termination. Will determine if the initiation of dexamethasone at the start of everolimus is associated with the incidence and of mild (score of 1-3), moderate (score of 4-6) and severe (score of 7-10) mouth pain as measured by the NAMPS. Will be assessed by Chi-square tests. | Original plan for collecting and analyzing this data did not occur due to study termination. | Posted | Up to 8 weeks |
|
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| Secondary | Time to Development of Mouth Pain | Original plan for collecting and analyzing this data did not occur due to study termination. Will determine if the initiation of dexamethasone at the start of everolimus is associated with the time to development of mild (score of 1-3), moderate (score of 4-6) and severe (score of 7-10) mouth pain as measured by the NAMPS. Will be assessed by Kaplan-Meier and cumulative incidence curves. | Original plan for collecting and analyzing this data did not occur due to study termination. | Posted | Up to 8 weeks |
|
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| Secondary | Quality of Life Assessed by Linear Analogue Self-Assessment | Original plan for collecting and analyzing this data did not occur due to study termination. Will determine if the initiation of dexamethasone at the start of everolimus is associated with quality of life is by comparing numerical analogue scale scores as measured by the Linear Analogue Self-Assessment. The Linear Analogue Self Assessment for quality of life is measured on a 0 to 10 scale, with 0 corresponding to "Quality of life as bad as it can be" and 10 corresponding to "Quality of life as good as it can be." Will be assessed by independent samples t-tests. | Original plan for collecting and analyzing this data did not occur due to study termination. | Posted | Up to 8 weeks |
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| Secondary | Mouth/Throat Sore Level of Activity Interference With Daily Activities | Original plan for collecting and analyzing this data did not occur due to study termination. Will determine if the initiation of dexamethasone at the start of everolimus is associated with the level of interference with daily activities as measured by the Patient Reported Outcome (PRO) Common Terminology criteria for Adverse Events (CTCAE) mouth/throat item regarding level of interference with daily activities. The PRO-CTCAE mouth/throat item regarding level of interference with daily activities is measured on a Likert 1-5 scale, with 1 corresponding to "Not at all" and 5 corresponding to "Very much." Will be assessed by independent samples t-tests. | Original plan for collecting and analyzing this data did not occur due to study termination. | Posted | Up to 8 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sleep Level of Activity Interference With Daily Activities | Original plan for collecting and analyzing this data did not occur due to study termination. Will determine if the initiation of dexamethasone at the start of everolimus is associated with the level of interference with daily activities as measured by the PRO-CTCAE sleep item regarding level of interference with daily activities. The PRO-CTCAE sleep item regarding level of interference with daily activities is measured on a Likert 1-5 scale, with 1 corresponding to "Not at all" and 5 corresponding to "Very much." Will be assessed by independent samples t-tests. | Original plan for collecting and analyzing this data did not occur due to study termination. | Posted | Up to 8 weeks |
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| Secondary | Adherence to Everolimus Therapy Dose | Original plan for collecting and analyzing this data did not occur due to study termination. Will compare mean daily dose of everolimus between the arms. The mean daily dose of everolimus over 8 weeks will be compared between study arms using independent samples t-tests. | Original plan for collecting and analyzing this data did not occur due to study termination. | Posted | Up to 8 weeks |
|
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| Secondary | Incidence of Patients Stopping Everolimus Early | Original plan for collecting and analyzing this data did not occur due to study termination. Will compare the number of patients who stopped everolimus early between the treatment arms. Will be compared using Chi-squared tests. | Original plan for collecting and analyzing this data did not occur due to study termination. | Posted | Up to 8 weeks |
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| Secondary | Incidence of Patients Reducing Everolimus Dose | Original plan for collecting and analyzing this data did not occur due to study termination. Will compare the number of patients who reduced their everolimus dose between the treatment arms. Will be compared using Chi-squared tests. | Original plan for collecting and analyzing this data did not occur due to study termination. | Posted | Up to 8 weeks |
|
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| Secondary | Dexamethasone Prescription Fill Rates | Original plan for collecting and analyzing this data did not occur due to study termination. Will compare dexamethasone prescription fill rates between the treatment groups. This will be compared using Chi-squared tests. | Original plan for collecting and analyzing this data did not occur due to study termination. | Posted | Up to 8 weeks |
|
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| Secondary | Time to Dexamethasone Prescription Fill | Original plan for collecting and analyzing this data did not occur due to study termination. Will compare the time to dexamethasone prescription fill between the treatment groups. This will be compared using Kaplan-Meier and cumulative incidence curves. | Original plan for collecting and analyzing this data did not occur due to study termination. | Posted | Up to 8 weeks |
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| Secondary | Time to Develop Mouth Sores Per Study Arm Assessed by PRO-CTCAE Mouth/Throat Sore Item Regarding Severity | Original plan for collecting and analyzing this data did not occur due to study termination. The time to develop at least mild, moderate, or severe (including "Very severe") mouth sores per study arm as measured by the PRO-CTCAE mouth-throat sore item regarding severity. The PRO-CTCAE mouth-throat sore item regarding severity is measured on a Likert 1-5 scale, with 1 corresponding to "None" and 5 corresponding to "Very severe". Will be assessed by Kaplan-Meier and cumulative incidence curves. | Original plan for collecting and analyzing this data did not occur due to study termination. | Posted | Up to 8 weeks |
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| Secondary | Mean Degrees of Patient-reported Mouth Sores Per Study Arm Assessed by NAMPS | Original plan for collecting and analyzing this data did not occur due to study termination. The mean degrees of patient-reported mouth sores per study arm as measured by the NAMPS will be assessed by independent samples t-tests. | Original plan for collecting and analyzing this data did not occur due to study termination. | Posted | Up to 8 weeks |
|
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| Secondary | Median Degree of Patient-reported Mouth Sores Per Study Arm Assessed by NAMPS | Original plan for collecting and analyzing this data did not occur due to study termination. The median degrees of patient-reported mouth sores per study arm as measured by the NAMPS will be assessed by independent samples t-tests. | Original plan for collecting and analyzing this data did not occur due to study termination. | Posted | Up to 8 weeks |
|
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| Secondary | Proportion of Patients Who Experience Grade 2 Stomatitis | Original plan for collecting and analyzing this data did not occur due to study termination. The proportion of patients who experience clinician-reported grade 2 stomatitis (as measured by the CTCAE and performed at 1 and 2 months post-baseline) per study arm will be assessed by Chi-squared tests. | Original plan for collecting and analyzing this data did not occur due to study termination. | Posted | Up to 2 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale by Sex | NIH-required analysis. The numerical analogue mouth pain score (NAMPS) is a single item measured on a 0 to 10 scale, with 0 corresponding to "No pain" and 10 corresponding to "Pain as bad as it can be." Will compare the incidence rate of any mouth pain (i.e., any score greater than 0) as assessed by the NAMPS between the prevention versus early treatment approaches using a Chi-square test. | Population is by Sex. Male and Female population combined equals Overall Number of Participants Analyzed. | Posted | Count of Participants | Participants | Up to 8 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale by Race | NIH-required analysis. The numerical analogue mouth pain score (NAMPS) is a single item measured on a 0 to 10 scale, with 0 corresponding to "No pain" and 10 corresponding to "Pain as bad as it can be." Will compare the incidence rate of any mouth pain (i.e., any score greater than 0) as assessed by the NAMPS between the prevention versus early treatment approaches using a Chi-square test. | Black or African American population is different than white population | Posted | Count of Participants | Participants | Up to 8 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale by Ethnicity. | NIH-required analysis. The numerical analogue mouth pain score (NAMPS) is a single item measured on a 0 to 10 scale, with 0 corresponding to "No pain" and 10 corresponding to "Pain as bad as it can be." Will compare the incidence rate of any mouth pain (i.e., any score greater than 0) as assessed by the NAMPS between the prevention versus early treatment approaches using a Chi-square test. | Population is by Ethnicity. Not Hispanic or Latino and Other population combined equals Overall Number of Participants Analyzed. | Posted | Count of Participants | Participants | Up to 8 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Severity of Mouth Pain Scores by Sex | Average Area Under the Curve per assessment (aAUCpa) of mouth pain scores as measured by NAMPS will be computed for each patient to summarize the sequence of numerical analogue mouth pain scores over the eight week study period. Scores are reported on a 0-100 scale, where 100 = better outcome QOL (i.e. less pain). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the end of the treatment at 8 weeks post-treatment-initiation and will be compared between the two treatment arms. | Population is by Sex. Male and Female population combined equals Overall Number of Participants Analyzed. | Posted | Mean | Inter-Quartile Range | scores on scale * days | Up to 8 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Severity of Mouth Pain Scores by Race | Average Area Under the Curve per assessment (aAUCpa) of mouth pain scores as measured by NAMPS will be computed for each patient to summarize the sequence of numerical analogue mouth pain scores over the eight week study period. Scores are reported on a 0-100 scale, where 100 = better outcome QOL (i.e. less pain). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the end of the treatment at 8 weeks post-treatment-initiation and will be compared between the two treatment arms. | Population is by Race. Black or African American and White population combined equals Overall Number of Participants Analyzed. | Posted | Mean | Inter-Quartile Range | scores on scale * days | Up to 8 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Severity of Mouth Pain Scores by Ethnicity | Average Area Under the Curve per assessment (aAUCpa) of mouth pain scores as measured by NAMPS will be computed for each patient to summarize the sequence of numerical analogue mouth pain scores over the eight week study period. Scores are reported on a 0-100 scale, where 100 = better outcome QOL (i.e. less pain). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the end of the treatment at 8 weeks post-treatment-initiation and will be compared between the two treatment arms. | Population is by Ethnicity. Not Hispanic or Latino and Other population combined equals Overall Number of Participants Analyzed. | Posted | Mean | Inter-Quartile Range | scores on scale * days | Up to 8 weeks |
|
8 weeks
3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group II (Placebo) | Everolimus: Standard of care | 0 | 19 | 3 | 18 | 16 | 18 |
| EG001 | Group I (Dexamethasone) | Everolimus: Standard of care | 0 | 20 | 2 | 17 | 12 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus tachycardia | Cardiac disorders | MedDRA 5 | Systematic Assessment |
| |
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Edema limbs | General disorders | MedDRA 5 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA 5 | Systematic Assessment |
| |
| Creatinine increased | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 5 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 5 | Systematic Assessment |
| |
| Blood and lymph sys disorders - Oth Spec | Blood and lymphatic system disorders | MedDRA 5 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Gastrointestinal disorders - Oth spec | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 5 | Systematic Assessment |
| |
| Mucosal infection | Infections and infestations | MedDRA 5 | Systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | MedDRA 5 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA 5 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Creatinine increased | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 5 | Systematic Assessment |
| |
| White blood cell decreased | Investigations | MedDRA 5 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA 5 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 5 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 5 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 5 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 5 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 5 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 5 | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA 5 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 5 | Systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | MedDRA 5 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kathryn J. Ruddy | Mayo Clinic | 507-293-1732 | ruddy.kathryn@mayo.edu |
| Feb 16, 2022 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D011795 | Surveys and Questionnaires |
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
Not provided
Not provided
| 50 - 65 years |
|
| >65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Other |
|
| 1 |
|
| 2 |
|
| > 0 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
| Participants |
|
| Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Pain |
|
| Pain |
|
| Pain |
|