Capsaicin Lozenges in Treating Patients With Mucositis Caused by Radiation Therapy

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 3

Conditions: Radiation Toxicity; Head and Neck Cancer

Treatments: Dietary Supplement: capsaicin; Radiation: radiation therapy; Other: placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00003610

CDR0000066687 (Registry Identifier)

NCCTG-969257

NCI-P98-0136

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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18 participants in 2 patient groups, including a placebo group

capsaicin + radiation therapy

Experimental group

Description:

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.

Treatment:

Dietary Supplement: capsaicin

Radiation: radiation therapy

placebo + radiation therapy

Placebo Comparator group

Description:

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.

Treatment:

Radiation: radiation therapy

Other: placebo