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| ID | Type | Description | Link |
|---|---|---|---|
| U10CA037447 | U.S. NIH Grant/Contract | View source | |
| UG1CA189823 | U.S. NIH Grant/Contract | View source | |
| NCI-2014-01877 | Registry Identifier | NCI Clinical Trials Reporting Office |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The purpose of this study is to test whether a mouthwash made with a drug called doxepin can reduce the pain caused by mouth sores resulting from radiation therapy. A number of mouth rinse preparations exist for patients with treatment-related oral mucositis pain such as the DLA rinse, an over-the-counter medication. This study will evaluate the effects of doxepin compared to DLA (diphenhydramine, lidocaine and antacids) and placebo.Doxepin is approved by the Food and Drug Administration (FDA) for the treatment of depression, anxiety, long-term pain management, as well as management of rash.
Patients are stratified according to sex (male vs. female), concurrent use of chemotherapy (no vs. yes), patient age at registration (< 60 years old vs. ≥ 60 years old and RTOG acute radiation morbidity criteria (1 vs. 2 vs 3 or more). Protocol therapy will consist of 2 cycles. Patients are randomized to one of three treatment regimens, which include doxepin, DLA and placebo. Cycle One will consist of one day. The care provider or nurse will confirm that the oral pain is at least 4 out of 10 severity level at the time of the rinse on the first day of the study. Patient will be asked to complete the baseline evaluation in the Oral Symptoms booklet. If the pain score is less than 4 then administration will be delayed until the pain is at least 4. Cycle Two will consist of an optional continuation phase lasting up to 7 days. Initiation of the Cycle 2/Continuation Phase may be delayed up to one week after Cycle 1/Day 1.
Primary Objective:
1. Determine whether the doxepin rinse or DLA rinse is more effective than placebo in reducing OM-related pain in patients undergoing RT to the oral cavity, as measured by a patient-reported questionnaire at baseline, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, and 4 hours.
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| doxepin rinse | Experimental | Patients receive 2.5 mL (25 mg) doxepin and 2.5 mL water orally. Doxepin rinse is administered in the clinic on Day 1 (Cycle 1). There is an optional continuation phase within seven days following Day 1 (Cycle 1), patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2) where the patient takes the rinse at home every 4 hours. Chemotherapy is allowed during the continuation phase. Patients randomized to doxepin or placebo, they and their caregivers will continue to be blinded to the treatment. Patients will complete the Oral Symptoms booklet per the protocol. |
|
| DLA (diphenhydramine, lidocaine and antacid) rinse | Active Comparator | Patients receive 5.0 mL DLA orally. DLA is administered in the clinic on Day 1 (Cycle 1). There is an optional continuation phase within seven days following Day 1 (Cycle 1), patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2) where the patient takes the rinse at home every 4 hours. Chemotherapy is allowed during the continuation phase. Patients receiving DLA during the continuation phase of the study, they and/or caregivers may be aware that they are receiving DLA. Patients will complete the Oral Symptoms booklet per the protocol. |
|
| placebo rinse | Placebo Comparator | Patients receive 2.5 mL placebo and 2.5 mL water orally. The placebo rinse is administered in the clinic on Day 1 (Cycle 1). There is an optional continuation phase within seven days following Day 1 (Cycle 1), patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2) where the patient takes the rinse at home every 4 hours. Chemotherapy is allowed during the continuation phase. Patients randomized to doxepin or placebo, they and their caregivers will continue to be blinded to the treatment. Patients will complete the Oral Symptoms booklet per the protocol. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| doxepin hydrochloride oral solution | Drug | 2.5 mL (25 mg) doxepin and 2.5 mL water administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Area Under the Curve (AUC) of Total Pain Reduction | Total pain reduction (mouth and throat) was measured by the numerical analogue scale of mouth pain on a scale of 0 to 10, with 0=no pain and 10=worst pain in the questionnaires taken at baseline, and 5, 15, 30, 60, 120, 240 minutes after assigned treatment for doxepin or DLA vs. placebo. The total pain reduction was calculated by the (average of mouth and throat) area under the curve (AUC) adjusting for baseline, with time scale (baseline, 5, 15, 30, 60, 120 and 240 minutes post treatment) replaced by a numerical scale of 0, 1, 2, 3, 4, 5 and 6 respectively. The AUC was prorated when there are terminal missing data. If the missing data were intermittent, simple imputation by trapezoidal rules were applied to calculate the AUC. If a patient cancelled, was missing baseline data, or only provided baseline data, he/she was excluded from the statistical analysis. | Baseline, 5, 15, 30, 60, 120, 240 minutes post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC) of Total Unpleasant Taste of the Oral Rinse | Total unpleasant taste was measured by the numerical analogue scale of taste of the oral rinse on a scale of 0 to 10, with 0=acceptable and 10=terrible in the questionnaires taken at 5, 15, 30, 60, 120, 240 minutes after assigned treatment for doxepin or DLA vs. placebo. The total unpleasant taste was calculated by the area under the curve (AUC) adjusting for 5 minutes post treatment, with time scale (5, 15, 30, 60, 120 and 240 minutes post treatment) replaced by a numerical scale of 1, 2, 3, 4 5 and 6 respectively. The AUC was prorated when there are terminal missing data. If the missing data were intermittent, simple imputation by trapezoidal rules were applied to calculate the AUC. If a patient cancelled, was missing 5 minutes after treatment data, or only provided 5 minutes after treatment data, he/she was excluded from the statistical analysis. |
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Documentation of Disease: Histologic documentation of malignancy currently undergoing a course of RT (with or without chemotherapy) including the oral cavity and/or oropharyngeal area to a dose of at least 4500 cGy using more than 5 fractions (i.e., stereotactic body radiation therapy [SBRT] is not allowed).
Physical exam demonstrating evidence of radiotherapy-related mucositis in the visible oral cavity and/or oropharynx consistent with mucous membrane toxicity greater than 0 using the Acute Radiation Morbidity Scoring Criteria.
At least 4 (out of 10) patient-reported oral pain related to oral mucositis secondary to RT for which the patient seeks relief, as measured on the Oral Pain Assessment.
Note: The pain score must be at least 4 at the time that the patient starts the first dose of study medication. The patient may be enrolled to the study if s/he, at times, has a pain score of at least 4, so long as initiation of study treatment begins when the pain score is at least 4.
Ability to complete questionnaire(s) by themselves or with assistance.
No known allergy to diphenhydramine, lidocaine, antacid (aluminum hydroxide, magnesium hydroxide, and simethicone), doxepin, tricyclic antidepressants, or any known component of the drug formulation in the testing arms.
No use of any anti-arrhythmic medication (except for beta-blockers) including lidocaine, linezolid, ipratropium, or medications with high anti-cholinergic potency (including neostigmine, a tricyclic antidepressant or a monoamine oxidase inhibitor) within 2 weeks prior to registration.
No current diagnosed untreated or unresolved oral candidiasis or oral HSV infection.
No history of untreated narrow angle glaucoma within 6 weeks prior to registration.
No untreated urinary retention within 6 weeks prior to registration.
No current use of glutamine or sucralfate powders at the time of registration (no washout required).
No cryotherapy for prophylactic mucosal protection within 6 weeks prior to registration.
Not pregnant, because patients eligible for this study will be receiving radiotherapy, which has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 28 days prior to registration is required.
Age ≥ 18 years
ECOG Performance Status 0, 1, or 2
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| Name | Affiliation | Role |
|---|---|---|
| Robert Miller, MD, MS | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anchorage Radiation Therapy Center | Anchorage | Alaska | 99504 | United States | ||
| Alaska Breast Care and Surgery LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30990550 | Derived | Sio TT, Le-Rademacher JG, Leenstra JL, Loprinzi CL, Rine G, Curtis A, Singh AK, Martenson JA Jr, Novotny PJ, Tan AD, Qin R, Ko SJ, Reiter PL, Miller RC. Effect of Doxepin Mouthwash or Diphenhydramine-Lidocaine-Antacid Mouthwash vs Placebo on Radiotherapy-Related Oral Mucositis Pain: The Alliance A221304 Randomized Clinical Trial. JAMA. 2019 Apr 16;321(15):1481-1490. doi: 10.1001/jama.2019.3504. |
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Total of 45 participants were excluded from all analyses due to 23 cancellations, 19 with mouth pain score<4 prior to treatment, 1 ineligible, 1 did not return questionnaire booklet and 1 inadvertently unblinding by study team.
Two-hundred and seventy-five participants (92 Doxepin, 91 DLA and 92 Placebo) were enrolled between November 2014 to May 2016. Data as of 8/21/2017 was summarized and reported.
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| ID | Title | Description |
|---|---|---|
| FG000 | Doxepin | Patients receive 2.5 mL (25 mg) doxepin and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2). |
| FG001 | DLA (Diphenhydramine, Lidocaine and Antacid) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Cycle 1 (Treatment Per Protocol) |
|
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|
| DLA (diphenhydramine, lidocaine and antacids) rinse | Drug | 5.0 mL administered orally |
|
| Placebo | Other | 2.5 mL placebo and 2.5 mL water administered orally |
|
| 5, 15, 30, 60, 120, 240 minutes post treatment |
| Area Under the Curve (AUC) of Total Stinging or Burning From the Oral Rinse | Total stinging or burning was measured by the numerical analogue scale of stinging or burning from the oral rinse on a scale of 0 to 10, with 0=no stinging or burning and 10=worst stinging or burning possible in the questionnaires taken at 5, 15, 30, 60, 120, 240 minutes after assigned treatment for doxepin or DLA vs. placebo. The total stinging or burning was calculated by the area under the curve (AUC) adjusting for 5 minutes post treatment, with time scale (5, 15, 30, 60, 120 and 240 minutes post treatment) replaced by a numerical scale of 1, 2, 3, 4 5 and 6 respectively. The AUC was prorated when there are terminal missing data. If the missing data were intermittent, simple imputation by trapezoidal rules were applied to calculate the AUC. If a patient cancelled, was missing 5 minutes after treatment data, or only provided 5 minutes after treatment data, he/she was excluded from the statistical analysis. | 5, 15, 30, 60, 120, 240 minutes post treatment |
| Area Under the Curve (AUC) of Total Drowsiness | Total drowsiness was measured by the numerical analogue scale of drowsiness on a scale of 0 to 10, with 0=no drowsiness and 10=extreme drowsiness, leading to sleep in the questionnaires taken at baseline, and 5, 15, 30, 60, 120, 240 minutes after assigned treatment for doxepin or DLA vs. placebo. The total drowsiness was calculated by the area under the curve (AUC) adjusting for baseline, with time scale (baseline, 5, 15, 30, 60, 120 and 240 minutes post treatment) replaced by a numerical scale of 0, 1, 2, 3, 4, 5 and 6 respectively. The AUC was prorated when there are terminal missing data. If the missing data were intermittent, simple imputation by trapezoidal rules were applied to calculate the AUC. If a patient cancelled, was missing baseline data, or only provided baseline data, he/she was excluded from the statistical analysis. | Baseline, 5, 15, 30, 60, 120, 240 minutes post treatment |
| The Incidence of Using Alternative Analgesics | Patients were asked if they have taken any other pain medications, if yes, to record the name, strength and when they have taken the pain medications in the 120 minutes and 240 minutes post treatment questionnaires. | At 120 and 240 minutes post treatment |
| Patient Preference for Continued Therapy With Oral Rinse After Initial Test Rinse Phase | Patients were asked: "Based on your experience with this current oral rinsing medication, would you want to take another dose now if it were available?" in the 240 minutes post treatment questionnaire. | At 240 minutes post treatment |
| Frequency of Study Rinse Used in the Continuation Phase | Patients were asked: "Did you use the study rinse today?" daily questionnaire during the optional continuation phase (Cycle 2). | Up to 7 days. |
| Median Mouth Pain Score in the Continuation Phase | Mouth pain scores was measured using the numerical analogue scale ranging from scale of 0 to 10, with 0=no pain and 10=worst pain daily during the optional continuation phase (Cycle 2). | Day 1 to Day 7 in the Continuation Phase |
| The Incidence of Using Alternative Analgesics in the Continuation Phase | Patients were asked if they have taken any medications for pain over the past 24 hours, if yes, to record the name, strength and when they have taken the pain medications daily during the optional continuation phase (Cycle 2). | Day 1 to Day 7 in the Continuation Phase |
| Anchorage |
| Alaska |
| 99508 |
| United States |
| Alaska Oncology and Hematology LLC | Anchorage | Alaska | 99508 | United States |
| Alaska Regional Hospital | Anchorage | Alaska | 99508 | United States |
| Alaska Women's Cancer Care | Anchorage | Alaska | 99508 | United States |
| Anchorage Oncology Centre | Anchorage | Alaska | 99508 | United States |
| Katmai Oncology Group | Anchorage | Alaska | 99508 | United States |
| Providence Alaska Medical Center | Anchorage | Alaska | 99508 | United States |
| Providence Saint Joseph Medical Center/Disney Family Cancer Center | Burbank | California | 91505 | 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 |
| Comprehensive Cancer Care and Research Institute of Colorado LLC | Englewood | California | 80113 | 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 CCOP | Oakland | California | 94609 | United States |
| Hematology and Oncology Associates-Oakland | Oakland | California | 94609 | United States |
| Rocky Mountain Cancer Centers-Aurora | Aurora | Colorado | 80012 | United States |
| The Medical Center of Aurora | Aurora | Colorado | 80012 | United States |
| Boulder Community Hospital | Boulder | Colorado | 80301 | United States |
| Rocky Mountain Cancer Centers-Boulder | Boulder | Colorado | 80304 | United States |
| Penrose-Saint Francis Healthcare | Colorado Springs | Colorado | 80907 | United States |
| Rocky Mountain Cancer Centers-Penrose | Colorado Springs | Colorado | 80907 | United States |
| Porter Adventist Hospital | Denver | Colorado | 80210 | United States |
| Exempla Saint Joseph Hospital | Denver | Colorado | 80218 | United States |
| Presbyterian - Saint Lukes Medical Center - Health One | Denver | Colorado | 80218 | United States |
| Rocky Mountain Cancer Centers-Midtown | Denver | Colorado | 80218 | United States |
| Rocky Mountain Cancer Centers-Rose | Denver | Colorado | 80220 | United States |
| Rose Medical Center | Denver | Colorado | 80220 | United States |
| Colorado Blood Cancer Institute | Denver | Colorado | 80907 | United States |
| Mercy Medical Center | Durango | Colorado | 81301 | United States |
| Southwest Oncology PC | Durango | Colorado | 81301 | United States |
| Swedish Medical Center | Englewood | Colorado | 80110 | United States |
| Mountain Blue Cancer Care Center | Golden | Colorado | 80401 | United States |
| North Colorado Medical Center | Greeley | Colorado | 80631 | United States |
| Rocky Mountain Cancer Centers-Greenwood Village | Greenwood Village | Colorado | 80111 | United States |
| Rocky Mountain Cancer Centers-Lakewood | Lakewood | Colorado | 80228 | United States |
| Saint Anthony Hospital | Lakewood | Colorado | 80228 | United States |
| Rocky Mountain Cancer Centers-Littleton | Littleton | Colorado | 80120 | United States |
| Littleton Adventist Hospital | Littleton | Colorado | 80122 | United States |
| Rocky Mountain Cancer Centers-Sky Ridge | Lone Tree | Colorado | 80124 | United States |
| Sky Ridge Medical Center | Lone Tree | Colorado | 80124 | United States |
| Longmont United Hospital | Longmont | Colorado | 80501 | United States |
| Rocky Mountain Cancer Centers-Longmont | Longmont | Colorado | 80501 | United States |
| McKee Medical Center | Loveland | Colorado | 80539 | United States |
| Parker Adventist Hospital | Parker | Colorado | 80138 | United States |
| Rocky Mountain Cancer Centers-Parker | Parker | Colorado | 80138 | United States |
| Saint Mary Corwin Medical Center | Pueblo | Colorado | 81004 | United States |
| Rocky Mountain Cancer Centers - Pueblo | Pueblo | Colorado | 81008 | United States |
| Rocky Mountain Cancer Centers-Thornton | Thornton | Colorado | 80260 | United States |
| Exempla Lutheran Medical Center | Wheat Ridge | Colorado | 80033 | United States |
| Saint Francis Hospital and Medical Center | Hartford | Connecticut | 06105 | United States |
| Middlesex Hospital | Middletown | Connecticut | 06457 | United States |
| Veterans Affairs Medical Center - Washington, DC | Washington D.C. | District of Columbia | 20422 | United States |
| Morton Plant Hospital | Clearwater | Florida | 33756 | United States |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital | Hollywood | Florida | 33021 | United States |
| Mount Sinai Medical Center | Miami Beach | Florida | 33140 | United States |
| Memorial Hospital West | Pembroke Pines | Florida | 33028 | United States |
| Saint Joseph's Hospital/Children's Hospital-Tampa | Tampa | Florida | 33607 | United States |
| Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho | 83706 | 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 | 61701 | United States |
| Saint Joseph Medical Center | Bloomington | Illinois | 61701 | United States |
| Illinois CancerCare - Canton | Canton | Illinois | 61520 | United States |
| Memorial Hospital of Carbondale | Carbondale | Illinois | 62902 | United States |
| Centralia Oncology Clinic | Centralia | Illinois | 62801 | United States |
| Cancer Care Specialists of Central Illinois | Decatur | Illinois | 62526 | United States |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | United States |
| Heartland Cancer Research NCORP | 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 |
| Garneau, Stewart C MD (UIA Investigator) | Moline | Illinois | 61265 | United States |
| Spector, David MD (UIA Investigator) | Moline | Illinois | 61265 | United States |
| Trinity Medical Center | Moline | Illinois | 61265 | United States |
| Illinois CancerCare- Ottawa Clinic | Ottawa | Illinois | 61350 | United States |
| Radiation Oncology of Northern Illinois | Ottawa | Illinois | 61350 | United States |
| Illinois CancerCare-Pekin | Pekin | Illinois | 61554 | United States |
| Pekin Cancer Treatment Center | Pekin | Illinois | 61554 | United States |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61603 | United States |
| OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC | Peoria | Illinois | 61615-7827 | United States |
| Illinois CancerCare-Peoria | Peoria | Illinois | 61615 | United States |
| OSF St. 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 |
| OSF Saint Anthony Medical Center | Rockford | Illinois | 61108 | United States |
| Central Illinois Hematology Oncology Center | Springfield | Illinois | 62702 | United States |
| Springfield Clinic | Springfield | Illinois | 62703 | United States |
| Memorial Medical Center | Springfield | Illinois | 62781-0001 | United States |
| Cancer Care Specialists of Illinois-Swansea | Swansea | Illinois | 62226 | United States |
| Memorial Regional Cancer Center Day Road | Mishawaka | Indiana | 46544 | United States |
| Memorial Hospital of South Bend | South Bend | Indiana | 46601 | United States |
| Constantinou, Costas L MD (UIA Investigator) | Bettendorf | Iowa | 52722 | United States |
| Mercy Hospital | Cedar Rapids | Iowa | 52403 | United States |
| Oncology Associates at Mercy Medical Center | Cedar Rapids | Iowa | 52403 | 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 |
| Iowa Lutheran Hospital | Des Moines | Iowa | 50316 | United States |
| Siouxland Regional Cancer Center | Sioux City | Iowa | 51101 | United States |
| Methodist West Hospital | West Des Moines | Iowa | 50266 | United States |
| Cancer Center of Kansas - Chanute | Chanute | Kansas | 66720 | United States |
| Cancer Center of Kansas - Dodge City | Dodge City | Kansas | 67801 | United States |
| Cancer Center of Kansas - El Dorado | El Dorado | Kansas | 67042 | United States |
| Cancer Center of Kansas - Fort Scott | Fort Scott | Kansas | 66701 | United States |
| Cancer Center of Kansas - Independence | Independence | Kansas | 67301 | United States |
| Cancer Center of Kansas - Kingman | Kingman | Kansas | 67068 | United States |
| Lawrence Memorial Hospital | Lawrence | Kansas | 66044 | United States |
| Cancer Center of Kansas - Liberal | Liberal | Kansas | 67901 | United States |
| Cancer Center of Kansas - Newton | Newton | Kansas | 67114 | United States |
| Cancer Center of Kansas - Parsons | Parsons | Kansas | 67357 | United States |
| Cancer Center of Kansas - Pratt | Pratt | Kansas | 67124 | United States |
| Cancer Center of Kansas - Salina | Salina | Kansas | 67401 | United States |
| Cancer Center of Kansas - Wellington | Wellington | Kansas | 67152 | United States |
| Associates In Womens Health | Wichita | Kansas | 67208 | United States |
| Cancer Center of Kansas - Wichita Medical Arts Tower | Wichita | Kansas | 67208 | United States |
| Cancer Center of Kansas - Main Office | Wichita | Kansas | 67214 | United States |
| Via Christi Regional Medical Center | Wichita | Kansas | 67214 | United States |
| Wesley Medical Center | Wichita | Kansas | 67214 | United States |
| Cancer Center of Kansas - Winfield | Winfield | Kansas | 67156 | United States |
| Maine Medical Center - Bramhall Campus | Portland | Maine | 04102 | United States |
| Saint Joseph Mercy Hospital | Ann Arbor | Michigan | 48106 | United States |
| Bronson Battle Creek | Battle Creek | Michigan | 49017 | United States |
| Oakwood Hospital and Medical Center | Dearborn | Michigan | 48124 | United States |
| Saint John Hospital and Medical Center | Detroit | Michigan | 48236 | United States |
| Green Bay Oncology - Escanaba | Escanaba | Michigan | 49431 | United States |
| Genesys Hurley Cancer Institute | Flint | Michigan | 48503 | United States |
| Hurley Medical Center | Flint | Michigan | 48503 | United States |
| Mercy Health Saint Mary's | Grand Rapids | Michigan | 49503 | United States |
| Spectrum Health at Butterworth Campus | Grand Rapids | Michigan | 49503 | United States |
| Green Bay Oncology - Iron Mountain | Iron Mountain | Michigan | 49801 | United States |
| Allegiance Health | Jackson | Michigan | 49201 | United States |
| Borgess Medical Center | Kalamazoo | Michigan | 49001 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007-3731 | United States |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | United States |
| Sparrow Hospital | Lansing | Michigan | 48912 | United States |
| Saint Mary Mercy Hospital | Livonia | Michigan | 48154 | United States |
| Mercy Health Mercy Campus | Muskegon | Michigan | 49444 | United States |
| Lakeland Community Hospital | Niles | Michigan | 49120 | United States |
| Saint Joseph Mercy Oakland | Pontiac | Michigan | 48341 | United States |
| Saint Joseph Mercy Port Huron | Port Huron | Michigan | 48060 | United States |
| Spectrum Health Reed City Hospital | Reed City | Michigan | 49677 | United States |
| William Beaumont Hospital - Royal Oak | Royal Oak | Michigan | 48073 | United States |
| Saint Mary's of Michigan | Saginaw | Michigan | 48601 | United States |
| Lakeland Hospital | 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 |
| William Beaumont Hospital - Troy | Troy | Michigan | 48098 | United States |
| Saint John Macomb-Oakland Hospital | Warren | Michigan | 48093 | United States |
| Sanford Clinic North-Bemidji | Bemidji | Minnesota | 56601 | 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 |
| Hutchinson Area Health Care | Hutchinson | Minnesota | 55350 | 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 |
| New Ulm Medical Center | New Ulm | Minnesota | 56073 | United States |
| North Memorial Medical Health Center | Robbinsdale | Minnesota | 55422 | United States |
| Mayo Clinic | 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 |
| 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 |
| Central Care Center - Carrie J. Babb Cancer Center | Bolivar | Missouri | 65613 | 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 |
| Capital Region Medical Center-Goldschmidt Cancer Center | Jefferson City | Missouri | 65109 | United States |
| Mercy Clinic-Rolla-Cancer and Hematology | Rolla | Missouri | 65401 | United States |
| Phelps County Regional Medical Center | Rolla | Missouri | 65401 | United States |
| Sainte Genevieve County Memorial Hospital | Sainte Genevieve | Missouri | 63670 | United States |
| Cancer Research for the Ozarks NCORP | Springfield | Missouri | 65804 | United States |
| Mercy Hospital Springfield | Springfield | Missouri | 65804 | United States |
| Cox Health 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 |
| Siteman Cancer Center-South County | St Louis | Missouri | 63129 | United States |
| Missouri Baptist Medical Center | St Louis | Missouri | 63131 | United States |
| Barnes-Jewish West County Hospital | St Louis | Missouri | 63141 | 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 |
| Comprehensive Cancer Centers of Nevada - Henderson | Henderson | Nevada | 89052 | United States |
| Las Vegas Cancer Center-Henderson | 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 |
| University Medical Center of Southern Nevada | Las Vegas | Nevada | 89102 | United States |
| Cancer and Blood Specialists-Henderson | Las Vegas | Nevada | 89106 | United States |
| Nevada Cancer Research Foundation NCORP | Las Vegas | Nevada | 89106 | United States |
| Radiation Oncology Centers 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 |
| 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 |
| Cancer and Blood Specialists-Shadow | 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 |
| Comprehensive Cancer Centers of Nevada-Summerlin | 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 |
| Cancer and Blood Specialists-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 |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | United States |
| Veterans Affairs Western New York Health Care System-Buffalo | Buffalo | New York | 14215 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| North Shore-LIJ Health System/Center for Advanced Medicine | New Hyde Park | New York | 11040 | United States |
| Randolph Hospital | Asheboro | North Carolina | 27203 | United States |
| Novant Health Presbyterian Medical Center | Charlotte | North Carolina | 28204 | United States |
| Carolina Surgical Clinic of Charlotte PA | Charlotte | North Carolina | 28207 | United States |
| Oncology Specialists of Charlotte | Charlotte | North Carolina | 28207 | United States |
| Southern Oncology Specialists-Charlotte | Charlotte | North Carolina | 28262 | United States |
| Southeastern Medical Oncology Center-Clinton | Clinton | North Carolina | 28328 | United States |
| CaroMont Regional Medical Center | Gastonia | North Carolina | 28054 | United States |
| Southeastern Medical Oncology Center-Goldsboro | Goldsboro | North Carolina | 27534 | United States |
| Wayne Memorial Hospital | Goldsboro | North Carolina | 27534 | United States |
| Cone Health Cancer Center | Greensboro | North Carolina | 27403 | United States |
| Hendersonville Hematology and Oncology at Pardee | Hendersonville | North Carolina | 28739 | United States |
| Margaret R Pardee Memorial Hospital | Hendersonville | North Carolina | 28791 | United States |
| Lake Norman Hematology Oncology Specialists-Huntersville | Huntersville | North Carolina | 28078 | United States |
| Southern Oncology Specialists-Huntersville | Huntersville | North Carolina | 28078 | United States |
| Lake Norman Hematology Oncology Specialists-Huntersville | Huntersville | North Carolina | 287078 | United States |
| Southeastern Medical Oncology Center-Jacksonville | Jacksonville | North Carolina | 28546 | United States |
| Novant Health Oncology Specialists-Kernersville | Kernersville | North Carolina | 27284 | United States |
| Novant Health Oncology Specialists-Davidson County | Lexington | North Carolina | 27295 | United States |
| Matthews Radiation Oncology Center | Matthews | North Carolina | 28105 | United States |
| Novant Health Cancer Specialists-Matthews | Matthews | North Carolina | 28105 | United States |
| Lake Norman Hematology Oncology Specialists-Mooresville | Mooresville | North Carolina | 28117 | United States |
| Novant Health Oncology Specialists-Mount Airy | Mount Airy | North Carolina | 27030 | United States |
| FirstHealth of the Carolinas-Moore Regional Hospital | Pinehurst | North Carolina | 28374 | United States |
| Annie Penn Memorial Hospital | Reidsville | North Carolina | 27320 | United States |
| Carolina Oncology Associates PA | Salisbury | North Carolina | 28144 | United States |
| Novant Health Oncology Specialists-Statesville | Statesville | North Carolina | 28625 | United States |
| Novant Health Oncology Specialists-Wilkesboro | Wilkesboro | North Carolina | 28659 | United States |
| Southeastern Medical Oncology Center-Wilson | Wilson | North Carolina | 27893 | United States |
| Novant Health Forsyth Medical Center | Winston-Salem | North Carolina | 27103 | United States |
| Novant Health Oncology Specialists | Winston-Salem | North Carolina | 27103 | United States |
| Winston-Salem Health Care | Winston-Salem | North Carolina | 27103 | United States |
| Sanford Bismarck Medical Center | Bismarck | North Dakota | 58501 | United States |
| Sanford Clinic North-Fargo | Fargo | North Dakota | 58102 | United States |
| Sanford Medical Center-Fargo | 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 |
| Mercy Hospital Oklahoma City | Oklahoma City | Oklahoma | 73120 | 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 |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Adams Cancer Center | Gettysburg | Pennsylvania | 17325 | United States |
| Geisinger Medical Center-Cancer Center Hazelton | Hazleton | Pennsylvania | 18201 | United States |
| Lewistown Hospital | Lewistown | Pennsylvania | 17044 | United States |
| Geisinger Medical Oncology-Pottsville | Pottsville | Pennsylvania | 17901 | United States |
| Geisinger Medical Group | State College | Pennsylvania | 16801 | United States |
| Geisinger Wyoming Valley/Henry Cancer Center | Wilkes-Barre | Pennsylvania | 18711 | United States |
| WellSpan Health-York Hospital | York | Pennsylvania | 17405 | United States |
| AnMed Health Cancer Center | Anderson | South Carolina | 29621 | United States |
| Beaufort Memorial Hospital | Beaufort | South Carolina | 29902 | United States |
| Greenville Health System Cancer Institute-Easley | Easley | South Carolina | 29640 | United States |
| Gibbs Cancer Center-Gaffney | Gaffney | South Carolina | 29341 | United States |
| Greenville Health System Cancer Institute - Butternut | Greenville | South Carolina | 29605 | United States |
| Greenville Health System Cancer Institute-Andrews | 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 |
| Gibbs Cancer Center-Pelham | Greer | South Carolina | 29651 | United States |
| Greenville Health System Cancer Institute-Seneca | Seneca | South Carolina | 29672 | United States |
| Spartanburg Medical Center | Spartanburg | South Carolina | 29303 | United States |
| Greenville Health System Cancer Institute-Spartanburg | Spartanburg | South Carolina | 29307 | United States |
| Avera Saint Luke's Hospital and Cancer Center | Aberdeen | South Dakota | 57401 | United States |
| Sanford Cancer Center Oncology Clinic | Sioux Falls | South Dakota | 57104 | United States |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | United States |
| Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | 57117 | United States |
| Martha Jefferson Hospital | Charlottesville | Virginia | 22901 | United States |
| Providence Regional Cancer System-Aberdeen | Aberdeen | Washington | 98520 | United States |
| Cancer Care Center at Island Hospital | Anacortes | Washington | 98221 | United States |
| Swedish Cancer Institute-Eastside Oncology Hematology | Bellevue | Washington | 98005 | 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 Medical Center - Issaquah | Issaquah | Washington | 98029 | United States |
| Providence Regional Cancer System-Lacey | Lacey | Washington | 98503 | United States |
| Saint John Medical Center | Longview | Washington | 98632 | United States |
| Minor and James Medical PLLC | Seattle | Washington | 98104 | United States |
| Pacific Gynecology Specialists | Seattle | Washington | 98104 | United States |
| Swedish Medical Center-Ballard Campus | Seattle | Washington | 98107 | United States |
| Group Health Cooperative-Seattle | Seattle | Washington | 98112 | United States |
| Swedish Medical Center-First Hill | Seattle | Washington | 98122 | United States |
| Providence Regional Cancer System-Shelton | Shelton | Washington | 98548 | United States |
| Rockwood Cancer Treatment Center-DHEC-Downtown | Spokane | Washington | 99204 | United States |
| Evergreen Hematology and Oncology PS | 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 |
| North Star Lodge Cancer Center at Yakima Valley Memorial Hospital | Yakima | Washington | 98902 | United States |
| Providence Regional Cancer System-Yelm | Yelm | Washington | 98597 | United States |
| Marshfield Clinic-Chippewa Center | Chippewa Falls | Wisconsin | 54729 | United States |
| Marshfield Clinic Cancer Center at Sacred Heart | Eau Claire | Wisconsin | 54701 | United States |
| Sacred Heart Hospital | Eau Claire | Wisconsin | 54701 | United States |
| Saint Agnes Hospital/Agnesian Cancer Center | Fond du Lac | Wisconsin | 54935 | United States |
| Green Bay Oncology at Saint Vincent Hospital | Green Bay | Wisconsin | 54301 | United States |
| Saint Vincent Hospital | Green Bay | Wisconsin | 54301 | United States |
| Green Bay Oncology Limited at Saint Mary's Hospital | Green Bay | Wisconsin | 54303 | United States |
| Saint Mary's Hospital | Green Bay | Wisconsin | 54303 | United States |
| Mayo Clinic Health System-Franciscan Healthcare | La Crosse | Wisconsin | 54601 | United States |
| Holy Family Memorial Hospital | Manitowoc | Wisconsin | 54221 | United States |
| Bay Area Medical Center | Marinette | Wisconsin | 54143 | United States |
| Marshfield Clinic | Marshfield | Wisconsin | 54449 | United States |
| Saint Joseph's Hospital | Marshfield | Wisconsin | 54449 | United States |
| Marshfield Clinic-Minocqua Center | Minocqua | Wisconsin | 54548 | United States |
| Westfields Hospital/Cancer Center of Western Wisconsin | New Richmond | Wisconsin | 54017 | United States |
| Green Bay Oncology - Oconto Falls | Oconto Falls | Wisconsin | 54154 | United States |
| Marshfield Clinic at James Beck Cancer Center | Rhinelander | Wisconsin | 54501 | United States |
| Marshfield Clinic-Rice Lake Center | Rice Lake | Wisconsin | 54868 | United States |
| Saint Nicholas Hospital | Sheboygan | Wisconsin | 53081 | United States |
| Marshfield Clinic at Saint Michael's Hospital | Stevens Point | Wisconsin | 54481 | United States |
| Saint Michael's Hospital | Stevens Point | Wisconsin | 54481 | United States |
| Door County Cancer Center | Sturgeon Bay | Wisconsin | 54235-1495 | United States |
| Green Bay Oncology - Sturgeon Bay | Sturgeon Bay | Wisconsin | 54235 | United States |
| Marshfield Clinic-Wausau Center | Wausau | Wisconsin | 54401 | United States |
| Diagnostic and Treatment Center | Weston | Wisconsin | 54476 | United States |
| Marshfield Clinic - Weston Center | Weston | Wisconsin | 54476 | United States |
| Saint Clare's Hospital | Weston | Wisconsin | 54476 | United States |
| Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids | Wisconsin | 54494 | United States |
| Cheyenne Regional Medical Center-West | Cheyenne | Wyoming | 82001 | United States |
Patients receive 5.0 mL DLA orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2). |
| FG002 | Placebo | Patients receive 2.5 mL placebo and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Cycle 2 (Optional Continuation Phase) |
|
|
All participants who met eligibility criteria, had mouth pain score of at least 4 on 0 to 10 scale with higher scores indicated worst pain and started the treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Doxepin | Patients receive 2.5 mL (25 mg) doxepin and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2). |
| BG001 | DLA (Diphenhydramine, Lidocaine and Antacid) | Patients receive 5.0 mL DLA orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2). |
| BG002 | Placebo | Patients receive 2.5 mL placebo and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2). |
| BG003 | 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 | Median | Full Range | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status | Count of Participants | Participants |
| ||||||||||||||||
| Concurrent use of chemotherapy | Count of Participants | Participants |
| ||||||||||||||||
| Mucous Membrane Grade | Mucous membrane grade:> >> 0=no change over baseline, 1=injection/may experience mild pain not requiring analgesic, 2=patchy mucositis which may produce an inflammatory serosanguinitis discharge/ may experience moderate pain requiring analgesia, 3=confluent fibrinous mucositis/ may include severe pain requiring narcotic, 4=Ulceration, hemorrhage or necrosis. | 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 | Mean Area Under the Curve (AUC) of Total Pain Reduction | Total pain reduction (mouth and throat) was measured by the numerical analogue scale of mouth pain on a scale of 0 to 10, with 0=no pain and 10=worst pain in the questionnaires taken at baseline, and 5, 15, 30, 60, 120, 240 minutes after assigned treatment for doxepin or DLA vs. placebo. The total pain reduction was calculated by the (average of mouth and throat) area under the curve (AUC) adjusting for baseline, with time scale (baseline, 5, 15, 30, 60, 120 and 240 minutes post treatment) replaced by a numerical scale of 0, 1, 2, 3, 4, 5 and 6 respectively. The AUC was prorated when there are terminal missing data. If the missing data were intermittent, simple imputation by trapezoidal rules were applied to calculate the AUC. If a patient cancelled, was missing baseline data, or only provided baseline data, he/she was excluded from the statistical analysis. | All participants who met eligibility criteria, had mouth pain score of at least 4 on 0 to 10 scale with higher scores indicated worst pain and started the treatment and had mouth and throat pain data at baseline and at least one time point beyond baseline. | Posted | Mean | Standard Deviation | units on a scale*time scale | Baseline, 5, 15, 30, 60, 120, 240 minutes post treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Curve (AUC) of Total Unpleasant Taste of the Oral Rinse | Total unpleasant taste was measured by the numerical analogue scale of taste of the oral rinse on a scale of 0 to 10, with 0=acceptable and 10=terrible in the questionnaires taken at 5, 15, 30, 60, 120, 240 minutes after assigned treatment for doxepin or DLA vs. placebo. The total unpleasant taste was calculated by the area under the curve (AUC) adjusting for 5 minutes post treatment, with time scale (5, 15, 30, 60, 120 and 240 minutes post treatment) replaced by a numerical scale of 1, 2, 3, 4 5 and 6 respectively. The AUC was prorated when there are terminal missing data. If the missing data were intermittent, simple imputation by trapezoidal rules were applied to calculate the AUC. If a patient cancelled, was missing 5 minutes after treatment data, or only provided 5 minutes after treatment data, he/she was excluded from the statistical analysis. | Posted | Median | Inter-Quartile Range | units on a scale*units on a scale | 5, 15, 30, 60, 120, 240 minutes post treatment |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Curve (AUC) of Total Stinging or Burning From the Oral Rinse | Total stinging or burning was measured by the numerical analogue scale of stinging or burning from the oral rinse on a scale of 0 to 10, with 0=no stinging or burning and 10=worst stinging or burning possible in the questionnaires taken at 5, 15, 30, 60, 120, 240 minutes after assigned treatment for doxepin or DLA vs. placebo. The total stinging or burning was calculated by the area under the curve (AUC) adjusting for 5 minutes post treatment, with time scale (5, 15, 30, 60, 120 and 240 minutes post treatment) replaced by a numerical scale of 1, 2, 3, 4 5 and 6 respectively. The AUC was prorated when there are terminal missing data. If the missing data were intermittent, simple imputation by trapezoidal rules were applied to calculate the AUC. If a patient cancelled, was missing 5 minutes after treatment data, or only provided 5 minutes after treatment data, he/she was excluded from the statistical analysis. | Posted | Median | Inter-Quartile Range | units on a scale*units on a scale | 5, 15, 30, 60, 120, 240 minutes post treatment |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Curve (AUC) of Total Drowsiness | Total drowsiness was measured by the numerical analogue scale of drowsiness on a scale of 0 to 10, with 0=no drowsiness and 10=extreme drowsiness, leading to sleep in the questionnaires taken at baseline, and 5, 15, 30, 60, 120, 240 minutes after assigned treatment for doxepin or DLA vs. placebo. The total drowsiness was calculated by the area under the curve (AUC) adjusting for baseline, with time scale (baseline, 5, 15, 30, 60, 120 and 240 minutes post treatment) replaced by a numerical scale of 0, 1, 2, 3, 4, 5 and 6 respectively. The AUC was prorated when there are terminal missing data. If the missing data were intermittent, simple imputation by trapezoidal rules were applied to calculate the AUC. If a patient cancelled, was missing baseline data, or only provided baseline data, he/she was excluded from the statistical analysis. | Posted | Median | Inter-Quartile Range | units on a scale*units on a scale | Baseline, 5, 15, 30, 60, 120, 240 minutes post treatment |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Incidence of Using Alternative Analgesics | Patients were asked if they have taken any other pain medications, if yes, to record the name, strength and when they have taken the pain medications in the 120 minutes and 240 minutes post treatment questionnaires. | Some patients are missing their Additional Analgesic Use. All participants who met eligibility criteria, had mouth pain score of at least 4 on 0 to 10 scale with higher scores indicated worst pain and started the treatment and has responded to the question about if they have taken any other pain medications at the indicated time point. | Posted | Count of Participants | Participants | At 120 and 240 minutes post treatment |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Patient Preference for Continued Therapy With Oral Rinse After Initial Test Rinse Phase | Patients were asked: "Based on your experience with this current oral rinsing medication, would you want to take another dose now if it were available?" in the 240 minutes post treatment questionnaire. | Posted | Count of Participants | Participants | At 240 minutes post treatment |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Frequency of Study Rinse Used in the Continuation Phase | Patients were asked: "Did you use the study rinse today?" daily questionnaire during the optional continuation phase (Cycle 2). | All participants who met eligibility criteria, had mouth pain score of at least 4 on 0 to 10 scale with higher scores indicated worst pain, completed the cycle 1 treatment, has started treatment in the optional continuation phase and has responded to the question. | Posted | Count of Participants | Participants | Up to 7 days. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Median Mouth Pain Score in the Continuation Phase | Mouth pain scores was measured using the numerical analogue scale ranging from scale of 0 to 10, with 0=no pain and 10=worst pain daily during the optional continuation phase (Cycle 2). | All participants who met eligibility criteria, had mouth pain score of at least 4 on 0 to 10 scale with higher scores indicated worst pain, completed the cycle 1 treatment, has started treatment in the optional continuation phase and has responded to the question. | Posted | Median | Full Range | units on a scale | Day 1 to Day 7 in the Continuation Phase |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Incidence of Using Alternative Analgesics in the Continuation Phase | Patients were asked if they have taken any medications for pain over the past 24 hours, if yes, to record the name, strength and when they have taken the pain medications daily during the optional continuation phase (Cycle 2). | All participants who met eligibility criteria, had mouth pain score of at least 4 on 0 to 10 scale with higher scores indicated worst pain and started the treatment and has responded to the question about if they have taken any other pain medications at the indicated time point. | Posted | Count of Participants | Participants | Day 1 to Day 7 in the Continuation Phase |
|
In clinic at 5, 15, 30, and 60 minutes after oral rinse and daily for up to 7 days, beginning within 1 week of Day 1.
All participants who met eligibility criteria, had mouth pain score of at least 4 on 0 to 10 scale with higher scores indicated worst pain, started the treatment and had adverse events assessed during the reporting period. Adverse events were not assessed on six participants (2 DLA and 4 Placebo).
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 | Doxepin | Patients receive 2.5 mL (25 mg) doxepin and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2). | 0 | 78 | 2 | 78 | 17 | 78 |
| EG001 | Placebo | Patients receive 2.5 mL placebo and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2). | 0 | 76 | 3 | 72 | 7 | 72 |
| EG002 | DLA (Diphenhydramine, Lidocaine and Antacid) | Patients receive 5.0 mL DLA orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2). | 0 | 76 | 3 | 74 | 8 | 74 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus tachycardia | Cardiac disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Fever | General disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Malaise | General disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Stoma site infection | Infections and infestations | CTCAEV4.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAEV4.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAEV4.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Esophageal pain | Gastrointestinal disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Gastrointestinal disorders - Oth spec | Gastrointestinal disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Oral dysesthesia | Gastrointestinal disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Gen disord and admin site conds-Oth spec | General disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Pain | General disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Bronchial infection | Infections and infestations | CTCAEV4.0 | Systematic Assessment |
| |
| Mucosal infection | Infections and infestations | CTCAEV4.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | CTCAEV4.0 | Systematic Assessment |
| |
| Stoma site infection | Infections and infestations | CTCAEV4.0 | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAEV4.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Akathisia | Nervous system disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Dysesthesia | Nervous system disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Body odor | Skin and subcutaneous tissue disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAEV4.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAEV4.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert C. Miller, MD, MS | Mayo Clinic | 904-953-1003 | miller.robert@mayo.edu |
| ID | Term |
|---|---|
| D004316 | Doxepin |
| D004155 | Diphenhydramine |
| D008012 | Lidocaine |
| D000863 | Antacids |
| ID | Term |
|---|---|
| D010082 | Oxepins |
| D004988 | Ethers, Cyclic |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D003990 | Dibenzoxepins |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005021 | Ethylamines |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D005765 | Gastrointestinal Agents |
| D045506 | Therapeutic Uses |
Not provided
Not provided
| Alternative Therapy |
|
| >=60 years old |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 1=Symptomatic and fully ambulatory |
|
| 2=Symptomatic, <50% in bed during the day |
|
| No |
|
| 2 |
|
| 3 or more |
|
| Superiority or Other (legacy) |
| OG002 | Placebo | Patients receive 2.5 mL placebo and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2). |
|
|
| OG002 | Placebo | Patients receive 2.5 mL placebo and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2). |
|
|
| OG002 | Placebo | Patients receive 2.5 mL placebo and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2). |
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|