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Capsaicin Lozenges in Treating Patients With Mucositis Caused by Radiation Therapy

Information source: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Head and Neck Cancer; Radiation Toxicity

Intervention: capsaicin (Dietary Supplement); placebo (Other); radiation therapy (Radiation)

Phase: Phase 3

Status: Completed

Sponsored by: Alliance for Clinical Trials in Oncology

Official(s) and/or principal investigator(s):
Scott Okuno, MD, Study Chair, Affiliation: Mayo Clinic

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.

Clinical Details

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

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

Primary outcome:

frequency of mouth pain

duration of mouth pain

severity of mouth pain

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

CCOP - Scottsdale Oncology Program, Scottsdale, Arizona 85259-5404, United States

CCOP - Illinois Oncology Research Association, Peoria, Illinois 61602, United States

CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States

CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa 52403-1206, United States

CCOP - Iowa Oncology Research Association, Des Moines, Iowa 10309-1016, United States

Siouxland Hematology-Oncology, Sioux City, Iowa 51101-1733, United States

CCOP - Wichita, Wichita, Kansas 67214-3882, United States

CCOP - Duluth, Duluth, Minnesota 55805, United States

Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States

CentraCare Clinic, Saint Cloud, Minnesota 56303, United States

CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska 68131, United States

Quain & Ramstad Clinic, P.C., Bismarck, North Dakota 58501, United States

Altru Health Systems, Grand Forks, North Dakota 58201, United States

CCOP - Toledo Community Hospital Oncology Program, Toledo, Ohio 43623-3456, United States

CCOP - Geisinger Clinical and Medical Center, Danville, Pennsylvania 17822-2001, United States

Rapid City Regional Hospital, Rapid City, South Dakota 57709, United States

CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota 57105-1080, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: October 1998
Last updated: July 7, 2015

Page last updated: August 20, 2015

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