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Spots Global Cancer Trial Database for Capsaicin Lozenges in Treating Patients With Mucositis Caused by Radiation Therapy

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Trial Identification

Brief Title: Capsaicin Lozenges in Treating Patients With Mucositis Caused by Radiation Therapy

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

Study ID: NCT00003610

Study Description

Brief 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.

Detailed 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

CCOP - Scottsdale Oncology Program, Scottsdale, Arizona, United States

CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States

CCOP - Carle Cancer Center, Urbana, Illinois, United States

CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa, United States

CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States

Siouxland Hematology-Oncology, Sioux City, Iowa, United States

CCOP - Wichita, Wichita, Kansas, United States

CCOP - Duluth, Duluth, Minnesota, United States

Mayo Clinic Cancer Center, Rochester, Minnesota, United States

CentraCare Clinic, Saint Cloud, Minnesota, United States

CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, United States

Quain & Ramstad Clinic, P.C., Bismarck, North Dakota, United States

Altru Health Systems, Grand Forks, North Dakota, United States

CCOP - Toledo Community Hospital Oncology Program, Toledo, Ohio, United States

CCOP - Geisinger Clinical and Medical Center, Danville, Pennsylvania, United States

Rapid City Regional Hospital, Rapid City, South Dakota, United States

CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota, United States

Contact Details

Name: Scott Okuno, MD

Affiliation: Mayo Clinic

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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