Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy
Completed · Phase 3 · Has a placebo group
Conditions studied: Acute Oral Mucositis Pain
In brief
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.
Key facts
- Study ID
- NCT02229539
- Run by
- Alliance for Clinical Trials in Oncology
- People needed
- 275
- Starts
- 2014-11-18
- Expected to finish
- 2019-03-15
- Last updated by the study team
- 2025-05-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Alaska Breast Care and Surgery LLC — Anchorage, Alaska, United States
- Alaska Oncology and Hematology LLC — Anchorage, Alaska, United States
- Alaska Regional Hospital — Anchorage, Alaska, United States
- Alaska Women's Cancer Care — Anchorage, Alaska, United States
- Anchorage Oncology Centre — Anchorage, Alaska, United States
- Katmai Oncology Group — Anchorage, Alaska, United States
- Providence Alaska Medical Center — Anchorage, Alaska, United States
- Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California, United States
- Epic Care-Dublin — Dublin, California, United States
- Bay Area Breast Surgeons Inc — Emeryville, California, United States
- Epic Care Partners in Cancer Care — Emeryville, California, United States
- Comprehensive Cancer Care and Research Institute of Colorado LLC — Englewood, California, United States
- Contra Costa Regional Medical Center — Martinez, California, United States
- Alta Bates Summit Medical Center - Summit Campus — Oakland, California, United States
- Bay Area Tumor Institute CCOP — Oakland, California, United States
- Hematology and Oncology Associates-Oakland — Oakland, California, United States
- Rocky Mountain Cancer Centers-Aurora — Aurora, Colorado, United States
- The Medical Center of Aurora — Aurora, Colorado, United States
- Boulder Community Hospital — Boulder, Colorado, United States
- Rocky Mountain Cancer Centers-Boulder — Boulder, Colorado, United States
- Penrose-Saint Francis Healthcare — Colorado Springs, Colorado, United States
- Rocky Mountain Cancer Centers-Penrose — Colorado Springs, Colorado, United States
- Porter Adventist Hospital — Denver, Colorado, United States
- Exempla Saint Joseph Hospital — Denver, Colorado, United States
- Anchorage Radiation Therapy Center — Anchorage, Alaska, United States
Full record on ClinicalTrials.gov
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