Capsaicin Lozenges in Treating Patients With Mucositis Caused by Radiation Therapy

OBJECTIVES: I. Determine the efficacy of capsaicin lozenges in terms of frequency, duration,
and severity of mouth pain caused by radiation therapy to the oral cavity. II. Evaluate the
toxicity of this regimen in these patients.

OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are
stratified according to dentures (yes vs no), smoking history (none vs currently vs past
only), radiation therapy (primary vs postoperative adjuvant), planned radiation dose
(5000-6000 cGy vs greater than 6000 cGy), planned fluoride use (yes vs no), and amount of
oral mucosa in radiation field (one- to two-thirds vs greater than two-thirds). Patients
receive one lozenge orally of capsaicin or 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.

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