Capsaicin Lozenges in Treating Patients With Mucositis Caused by Radiation Therapy
Head and Neck Cancer, Radiation Toxicity
About this trial
This is an interventional supportive care trial for Head and Neck Cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Scheduled to receive radiation treatment to at least one third of the oral cavity at a total dose of at least 5000 cGy using 200 cGy/fraction Must be entered on study within first 3 days of radiation No open mouth sores at study entry PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No known intolerance to capsaicin No allergy to citric acid, cherry flavorings, or FC and C red dye #3 or #40 PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the oral mucosa Surgery: Not specified Other: No requirement for tube feeding
Sites / Locations
- CCOP - Scottsdale Oncology Program
- CCOP - Illinois Oncology Research Association
- CCOP - Carle Cancer Center
- CCOP - Cedar Rapids Oncology Project
- CCOP - Iowa Oncology Research Association
- Siouxland Hematology-Oncology
- CCOP - Wichita
- CCOP - Duluth
- Mayo Clinic Cancer Center
- CentraCare Clinic
- CCOP - Missouri Valley Cancer Consortium
- Quain & Ramstad Clinic, P.C.
- Altru Health Systems
- CCOP - Toledo Community Hospital Oncology Program
- CCOP - Geisinger Clinical and Medical Center
- Rapid City Regional Hospital
- CCOP - Sioux Community Cancer Consortium
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
capsaicin + radiation therapy
placebo + radiation therapy
Patients receive one lozenge orally of capsaicin four times daily. Treatment begins within the first 3 days of radiation therapy and continues during and for two weeks after radiation therapy is completed.
Patients receive one lozenge orally of placebo four times daily. Treatment begins within the first 3 days of radiation therapy and continues during and for two weeks after radiation therapy is completed.