Head and Neck Cancer Clinical Trial
Official title:
Phase III Comparison of Oral Capsaicin Lozenge Versus Placebo Lozenge for Radiation-Induced Mucositis
RATIONALE: Capsaicin lozenges may be effective treatment for mucositis caused by radiation
therapy. It is not yet known whether capsaicin lozenges are more effective than no treatment
for mucositis caused by radiation therapy.
PURPOSE: Randomized phase III trial to study the effectiveness of 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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
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