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NCT00003610 Clinical Trial

Capsaicin Lozenges in Treating Patients With Mucositis Caused by Radiation Therapy

Head and Neck Cancer Clinical Trial

Official title:
Phase III Comparison of Oral Capsaicin Lozenge Versus Placebo Lozenge for Radiation-Induced Mucositis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00003610
Other study ID # NCCTG-969257
Secondary ID CDR0000066687NCI
Status Completed
Phase Phase 3
First received November 1, 1999
Last updated July 12, 2016
Start date October 1998
Est. completion date July 2006

Study information
Verified date July 2016
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date July 2006
Est. primary completion date July 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• capsaicin

Other:
• placebo

Radiation:
• radiation therapy

Locations
Country Name City State
United States Quain & Ramstad Clinic, P.C. Bismarck North Dakota
United States CCOP - Cedar Rapids Oncology Project Cedar Rapids Iowa
United States CCOP - Geisinger Clinical and Medical Center Danville Pennsylvania
United States CCOP - Iowa Oncology Research Association Des Moines Iowa
United States CCOP - Duluth Duluth Minnesota
United States Altru Health Systems Grand Forks North Dakota
United States CCOP - Missouri Valley Cancer Consortium Omaha Nebraska
United States CCOP - Illinois Oncology Research Association Peoria Illinois
United States Rapid City Regional Hospital Rapid City South Dakota
United States Mayo Clinic Cancer Center Rochester Minnesota
United States CentraCare Clinic Saint Cloud Minnesota
United States CCOP - Scottsdale Oncology Program Scottsdale Arizona
United States Siouxland Hematology-Oncology Sioux City Iowa
United States CCOP - Sioux Community Cancer Consortium Sioux Falls South Dakota
United States CCOP - Toledo Community Hospital Oncology Program Toledo Ohio
United States CCOP - Carle Cancer Center Urbana Illinois
United States CCOP - Wichita Wichita Kansas

Sponsors (2)
Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary frequency of mouth pain Up to 2 weeks post-radiation treatment No
Primary duration of mouth pain Up to 2 weeks post-radiation treatment No
Primary severity of mouth pain Up to 2 weeks post-radiation treatment No
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