Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-00790 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| URCC16092 | Other Identifier | University of Rochester NCORP Research Base | |
| URCC-16092 | Other Identifier | DCP | |
| URCC-16092 | Other Identifier | CTEP | |
| R21CA187500 | U.S. NIH Grant/Contract | View source | |
| UG1CA189961 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
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This randomized phase II trial studies how well low-dose ibuprofen in improving cognitive impairment in patients with cancer. Anti-inflammatory agents, such as ibuprofen, may slow the decline of cognitive processes and diseases involving the brain.
PRIMARY OBJECTIVES:
I. To provide preliminary data on the effect of ibuprofen on alleviating chemotherapy-related cognitive impairment (CRCI) in cancer patients receiving chemotherapy or who have received chemotherapy within the last 6 months compared to a placebo control, as assessed by the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog).
OUTLINE: Patients are randomized into 1 of 2 arms.
ARM I: Patients receive ibuprofen orally (PO) twice daily (BID) for 6 weeks.
ARM II: Patients receive placebo PO BID for 6 weeks.
After completion of study, patients are followed up periodically.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (ibuprofen) | Experimental | Patients receive ibuprofen PO BID for 6 weeks. |
|
| Arm II (placebo) | Placebo Comparator | Patients receive placebo PO BID for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen | Drug | Given PO |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Effects of Ibuprofen on Alleviating Chemotherapy-related Cognitive Impairment | Will be assessed by the Functional Assessment of Cancer Therapy-Cognitive Function. Means, standard deviations, and 95% confidence intervals will be determined in order to estimate preliminary population variances and effect sizes. These statistical measures will be calculated by group for the Pre(Baseline) and Post(6 Weeks) measures of the Functional Assessment of Cancer Therapy-Cognitive Function scores as well as the change (post-pre) in the scores using the subjects that completed the study (complete case estimation). The complete case estimates will be compared to multiple imputation estimates based on all subjects that completed pre-intervention. An analysis of covariance will be run using Functional Assessment of Cancer Therapy-Cognitive Function post-intervention as the response. Higher scores indicate better function; range is 0 to 148. | Up to 41 days post-intervention |
Not provided
Not provided
Inclusion Criteria:
Have a diagnosis of cancer and have had surgery and are now receiving adjuvant or neoadjuvant chemotherapy or who have received chemotherapy within the last 6 months; chemotherapy with concurrent radiation therapy (RT) is allowed
Answer YES to the question: "Have you noticed any problems in your memory, attention, concentration, multi-tasking or other cognitive functions?" any time after initiation of chemotherapy cycle 1
Be able to swallow medication
Be able to read English
Have the ability to understand and to give written informed consent as assessed by the participant's primary care physician or medical oncologist
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Michelle C Janelsins | University of Rochester NCORP Research Base | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence Saint Joseph Medical Center/Disney Family Cancer Center | Burbank | California | 91505 | United States | ||
Not provided
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Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Ibuprofen) | Patients receive ibuprofen PO BID for 6 weeks. Ibuprofen: Given PO Questionnaire Administration: Ancillary studies |
| FG001 | Arm II (Placebo) | Patients receive placebo PO BID for 6 weeks. Placebo: Given PO Questionnaire Administration: Ancillary studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| 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 | Apr 22, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Given PO |
|
|
| Questionnaire Administration | Other | Ancillary studies |
|
| Beebe Medical Center |
| Lewes |
| Delaware |
| 19958 |
| United States |
| Delaware Clinical and Laboratory Physicians PA | Newark | Delaware | 19713 | United States |
| Helen F Graham Cancer Center | Newark | Delaware | 19713 | United States |
| Medical Oncology Hematology Consultants PA | Newark | Delaware | 19713 | United States |
| Regional Hematology and Oncology PA | Newark | Delaware | 19713 | United States |
| Christiana Care Health System-Christiana Hospital | Newark | Delaware | 19718 | United States |
| Beebe Health Campus | Rehoboth Beach | Delaware | 19971 | United States |
| Nanticoke Memorial Hospital | Seaford | Delaware | 19973 | United States |
| Christiana Care Health System-Wilmington Hospital | Wilmington | Delaware | 19801 | United States |
| Saint Luke's Mountain States Tumor Institute | Boise | Idaho | 83712 | United States |
| Saint Luke's Mountain States Tumor Institute - Fruitland | Fruitland | Idaho | 83619 | United States |
| Saint Luke's Mountain States Tumor Institute - Meridian | Meridian | Idaho | 83642 | United States |
| Saint Luke's Mountain States Tumor Institute - Nampa | Nampa | Idaho | 83686 | United States |
| Saint Luke's Mountain States Tumor Institute-Twin Falls | Twin Falls | Idaho | 83301 | 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 |
| Cancer Care Specialists of Illinois - Decatur | Decatur | Illinois | 62526 | United States |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | 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 |
| Illinois CancerCare-Ottawa Clinic | Ottawa | Illinois | 61350 | United States |
| Illinois CancerCare-Pekin | Pekin | Illinois | 61554 | United States |
| OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center | Pekin | Illinois | 61554 | United States |
| Illinois CancerCare-Peoria | Peoria | Illinois | 61615 | United States |
| OSF Saint Francis Radiation Oncology at Peoria Cancer Center | Peoria | Illinois | 61615 | United States |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61636 | United States |
| OSF Saint Francis Medical Center | Peoria | Illinois | 61637 | 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 |
| Cancer Care Specialists of Illinois-Swansea | Swansea | Illinois | 62226 | United States |
| Southwest Illinois Health Services LLP | Swansea | Illinois | 62226 | United States |
| Bronson Battle Creek | Battle Creek | Michigan | 49017 | United States |
| Mercy Health Saint Mary's | Grand Rapids | Michigan | 49503 | United States |
| Spectrum Health at Butterworth Campus | Grand Rapids | Michigan | 49503 | 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 |
| Mercy Health Mercy Campus | Muskegon | Michigan | 49444 | United States |
| Lakeland Hospital Niles | Niles | Michigan | 49120 | United States |
| Spectrum Health Reed City Hospital | Reed City | Michigan | 49677 | United States |
| Lakeland Medical Center Saint Joseph | Saint Joseph | Michigan | 49085 | United States |
| Marie Yeager Cancer Center | Saint Joseph | Michigan | 49085 | United States |
| Munson Medical Center | Traverse City | Michigan | 49684 | United States |
| Metro Health Hospital | Wyoming | Michigan | 49519 | United States |
| Fairview Ridges Hospital | Burnsville | Minnesota | 55337 | 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 Maple Grove Medical Center | 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 |
| North Memorial Medical Health Center | Robbinsdale | Minnesota | 55422 | 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 |
| 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 |
| Fairview Lakes Medical Center | Wyoming | Minnesota | 55092 | United States |
| Parkland Health Center-Bonne Terre | Bonne Terre | Missouri | 63628 | United States |
| Saint Francis Medical Center | Cape Girardeau | Missouri | 63703 | United States |
| Southeast Cancer Center | Cape Girardeau | Missouri | 63703 | United States |
| Capital Region Southwest Campus | Jefferson City | Missouri | 65109 | United States |
| Sainte Genevieve County Memorial Hospital | Sainte Genevieve | Missouri | 63670 | United States |
| Missouri Baptist Medical Center | St Louis | Missouri | 63131 | United States |
| Missouri Baptist Sullivan Hospital | Sullivan | Missouri | 63080 | United States |
| Missouri Baptist Outpatient Center-Sunset Hills | Sunset Hills | Missouri | 63127 | 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 |
| Desert West Surgery | 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 |
| OptumCare Cancer Care at Oakey | 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 |
| HealthCare Partners Medical Group Oncology/Hematology-San Martin | Las Vegas | Nevada | 89113 | United States |
| Radiation Oncology Centers of Nevada Southeast | Las Vegas | Nevada | 89119 | United States |
| Cancer Therapy and Integrative Medicine | Las Vegas | Nevada | 89121 | 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 |
| OptumCare Cancer Care at MountainView | Las Vegas | Nevada | 89128 | 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 |
| 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 |
| Cancer Care of Western North Carolina | Asheville | North Carolina | 28801 | United States |
| Mission Hospital Inc-Memorial Campus | Asheville | North Carolina | 28801 | United States |
| Hope Women's Cancer Centers-Asheville | Asheville | North Carolina | 28816 | United States |
| Marietta Memorial Hospital | Columbus | Ohio | 43215 | United States |
| Saint Charles Health System | Bend | Oregon | 97701 | United States |
| Clackamas Radiation Oncology Center | Clackamas | Oregon | 97015 | United States |
| Providence Oncology and Hematology Care Southeast | Clackamas | Oregon | 97015 | United States |
| Bay Area Hospital | Coos Bay | Oregon | 97420 | United States |
| Providence Newberg Medical Center | Newberg | Oregon | 97132 | United States |
| Providence Willamette Falls Medical Center | Oregon City | Oregon | 97045 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| Providence Saint Vincent Medical Center | Portland | Oregon | 97225 | United States |
| Christiana Care Health System-Concord Health Center | Chadds Ford | Pennsylvania | 19317 | United States |
| Greenville Health System Cancer Institute-Laurens | Clinton | South Carolina | 29325 | United States |
| Greenville Health System Cancer Institute-Easley | Easley | South Carolina | 29640 | United States |
| Greenville Health System Cancer Institute-Butternut | Greenville | South Carolina | 29605 | United States |
| Greenville Health System Cancer Institute-Faris | Greenville | South Carolina | 29605 | United States |
| Greenville Memorial Hospital | Greenville | South Carolina | 29605 | United States |
| Greenville Health System Cancer Institute-Eastside | Greenville | South Carolina | 29615 | United States |
| Greenville Health System Cancer Institute-Greer | Greer | South Carolina | 29650 | United States |
| Greenville Health System Cancer Institute-Seneca | Seneca | South Carolina | 29672 | United States |
| Greenville Health System Cancer Institute-Spartanburg | Spartanburg | South Carolina | 29307 | United States |
| Providence Regional Cancer System-Aberdeen | Aberdeen | Washington | 98520 | United States |
| Cancer Care Center at Island Hospital | Anacortes | Washington | 98221 | United States |
| PeaceHealth Saint Joseph Medical Center | Bellingham | Washington | 98225 | United States |
| Providence Regional Cancer System-Centralia | Centralia | Washington | 98531 | United States |
| Swedish Medical Center-Edmonds | Edmonds | Washington | 98026 | United States |
| Providence Regional Cancer Partnership | Everett | Washington | 98201 | United States |
| Swedish Cancer Institute-Issaquah | Issaquah | Washington | 98029 | United States |
| Kadlec Clinic Hematology and Oncology | Kennewick | Washington | 99336 | United States |
| Providence Regional Cancer System-Lacey | Lacey | Washington | 98503 | United States |
| PeaceHealth Saint John Medical Center | Longview | Washington | 98632 | United States |
| Pacific Gynecology Specialists | Seattle | Washington | 98104 | United States |
| Swedish Medical Center-Ballard Campus | Seattle | Washington | 98107 | United States |
| Kaiser Permanente Washington | Seattle | Washington | 98112 | United States |
| Swedish Medical Center-First Hill | Seattle | Washington | 98122-4307 | United States |
| Swedish Medical Center-Cherry Hill | Seattle | Washington | 98122-5711 | United States |
| Providence Regional Cancer System-Shelton | Shelton | Washington | 98584 | United States |
| Rockwood Cancer Treatment Center-DHEC-Downtown | Spokane | Washington | 99204 | United States |
| Rockwood North Cancer Treatment Center | Spokane | Washington | 99218 | United States |
| Rockwood Clinic Cancer Treatment Center-Valley | Spokane Valley | Washington | 99216 | United States |
| PeaceHealth Southwest Medical Center | Vancouver | Washington | 98664 | United States |
| Providence Saint Mary Regional Cancer Center | Walla Walla | Washington | 99362 | United States |
| Providence Regional Cancer System-Yelm | Yelm | Washington | 98597 | United States |
| Cancer Center of Western Wisconsin | New Richmond | Wisconsin | 54017 | United States |
| Received Intervention and Completed Baseline Assessments |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ibuprofen 200mg BID | 200mg ibuprofen (taken twice a day at least 8 hours apart) for a period of 6 weeks. Ibuprofen: 200 mg BID and 8 hours apart |
| BG001 | Placebo | 200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks. Placebo: 200mg BID and 8 hours apart |
| 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 |
| |||||||||||||||
| 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 |
| ||||||||||||||||
| Education Level | Count of Participants | Participants |
| ||||||||||||||||
| Cancer Stage | Stage 1.This stage is usually a small cancer or tumor that has not grown deeply into nearby tissues. It also has not spread to the lymph nodes or other parts of the body. Stage 2 and 3.These stages indicate larger cancers or tumors that have grown more deeply into nearby tissue. They may have also spread to lymph nodes but not other parts of the body. Stage 4.This stage means that the cancer has spread to other organs or parts of the body. It may also be called metastatic cancer. Stage 1 is best, Stage 4 is worst. | Count of Participants | Participants |
| |||||||||||||||
| Chemotherapy | 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 | Effects of Ibuprofen on Alleviating Chemotherapy-related Cognitive Impairment | Will be assessed by the Functional Assessment of Cancer Therapy-Cognitive Function. Means, standard deviations, and 95% confidence intervals will be determined in order to estimate preliminary population variances and effect sizes. These statistical measures will be calculated by group for the Pre(Baseline) and Post(6 Weeks) measures of the Functional Assessment of Cancer Therapy-Cognitive Function scores as well as the change (post-pre) in the scores using the subjects that completed the study (complete case estimation). The complete case estimates will be compared to multiple imputation estimates based on all subjects that completed pre-intervention. An analysis of covariance will be run using Functional Assessment of Cancer Therapy-Cognitive Function post-intervention as the response. Higher scores indicate better function; range is 0 to 148. | Whenever the 6-week number of subjects or baseline number of subjects is less than the number reported per arm this is due to the data not being available. n=36 for Placebo (3-withdrawal by subject, 1- withdrawal due to medical issue) ; n=37 for Ibuprofen (3-withdrawal by subject, 3 - withdrawal due to medical issue, 1-lost to follow-up*) | Posted | Mean | Standard Deviation | score on a scale | Up to 41 days post-intervention |
|
|
|
|
Adverse events were collected during the study intervention period. Approximately 6 weeks
Adverse event definition does not differ from clinicaltrials.gov definition. A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or is an important medical event.
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 | Ibuprofen 200 mg BID | 200mg ibuprofen (taken twice a day at least 8 hours apart) for a period of 6 weeks. Ibuprofen: 200 mg BID and 8 hours apart | 0 | 45 | 2 | 45 | 15 | 45 |
| EG001 | Placebo | 200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks. Placebo: 200mg BID and 8 hours apart | 0 | 42 | 3 | 42 | 15 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Enterocolitis infectious | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Enterocolitis infectious | Infections and infestations | Non-systematic Assessment |
| ||
| Creatinine increased | Investigations | Non-systematic Assessment |
| ||
| Creatinine increased | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Cystitis noninfective | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Arterial thromboembolism | Vascular disorders | Non-systematic Assessment |
| ||
| Hypotension | Vascular disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Hypokalemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Lymphocyte count decreased | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Platelet count decreased | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Atrial flutter | Cardiac disorders | Non-systematic Assessment |
| ||
| Chest wall pain | Cardiac disorders | Non-systematic Assessment |
| ||
| Sinus bradycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Sinus tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Supraventricular tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastroesophageal reflux disease | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastrointestinal Pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Mucositis oral | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Esophageal infection | Infections and infestations | Non-systematic Assessment |
| ||
| Anemia | Investigations | Non-systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Non-systematic Assessment |
| ||
| Thromboembolic Event | Investigations | Non-systematic Assessment |
| ||
| White blood cell decreased | Investigations | Non-systematic Assessment |
| ||
| Hyperkalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypoalbuminemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Back Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Bone Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Syncope | Nervous system disorders | Non-systematic Assessment |
| ||
| Fatigue | Psychiatric disorders | Non-systematic Assessment |
| ||
| Proteinuria | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Dermatitis Radiation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Hyperhidrosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Papulopustular rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Flushing | Vascular disorders | Non-systematic Assessment |
| ||
| Hot flashes | Vascular disorders | Non-systematic Assessment |
| ||
| Hypotension | Vascular disorders | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle Janelsins, PhD, MPH | University of Rochester Medical Center, Dept of Surgery, Supportive Care in Cancer | 585-276-4656 | michelle_janelsins@urmc.rochester.edu |
| Mar 28, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
| 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 |
|
| Colorectal |
|
| Other |
|
| Unknown or Not Reported |
|
| Highschool/GED |
|
| Less than 4 Year Degree |
|
| 4 Year Degree |
|
| Graduate Degree |
|
| Unknown or Not Reported |
|
| Stage 2 |
|
| Stage 3 |
|
| Stage 4 |
|
| Unknown or Not Reported |
|
| Not Actively Receiving |
|
| Unknown or Not Reported |
|
| 6 Weeks (Post) |
|
|
| Change from Baseline(Post - Pre) |
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|