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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003610 |
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.
Condition | Intervention | Phase |
Head and Neck Cancer Oral Complications of Cancer and Cancer Therapy Radiation Toxicity |
Drug: capsaicin |
Phase III |
MedlinePlus related topics: | Cancer Head and Neck Cancer Salivary Gland Disorders |
ChemIDplus related topics: | Salicylsalicylic acid Sodium salicylate Capsaicin |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized |
Official Title: | Phase III Comparison of Oral Capsaicin Lozenge Versus Placebo Lozenge for Radiation-Induced Mucositis |
Study Start Date: | October 1998 |
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.
PROJECTED ACCRUAL: A total of 120 patients (60/arm) will be accrued for this study within 6 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
United States, Arizona | |||||
CCOP - Scottsdale Oncology Program | |||||
Scottsdale, Arizona, United States, 85259-5404 | |||||
United States, Illinois | |||||
CCOP - Carle Cancer Center | |||||
Urbana, Illinois, United States, 61801 | |||||
CCOP - Illinois Oncology Research Association | |||||
Peoria, Illinois, United States, 61602 | |||||
United States, Iowa | |||||
CCOP - Cedar Rapids Oncology Project | |||||
Cedar Rapids, Iowa, United States, 52403-1206 | |||||
CCOP - Iowa Oncology Research Association | |||||
Des Moines, Iowa, United States, 10309-1016 | |||||
Siouxland Hematology-Oncology | |||||
Sioux City, Iowa, United States, 51101-1733 | |||||
United States, Kansas | |||||
CCOP - Wichita | |||||
Wichita, Kansas, United States, 67214-3882 | |||||
United States, Minnesota | |||||
CCOP - Duluth | |||||
Duluth, Minnesota, United States, 55805 | |||||
CentraCare Clinic | |||||
Saint Cloud, Minnesota, United States, 56303 | |||||
Mayo Clinic Cancer Center | |||||
Rochester, Minnesota, United States, 55905 | |||||
United States, Nebraska | |||||
CCOP - Missouri Valley Cancer Consortium | |||||
Omaha, Nebraska, United States, 68131 | |||||
United States, North Dakota | |||||
Altru Health Systems | |||||
Grand Forks, North Dakota, United States, 58201 | |||||
Quain & Ramstad Clinic, P.C. | |||||
Bismarck, North Dakota, United States, 58501 | |||||
United States, Ohio | |||||
CCOP - Toledo Community Hospital Oncology Program | |||||
Toledo, Ohio, United States, 43623-3456 | |||||
United States, Pennsylvania | |||||
CCOP - Geisinger Clinical and Medical Center | |||||
Danville, Pennsylvania, United States, 17822-2001 | |||||
United States, South Dakota | |||||
CCOP - Sioux Community Cancer Consortium | |||||
Sioux Falls, South Dakota, United States, 57105-1080 | |||||
Rapid City Regional Hospital | |||||
Rapid City, South Dakota, United States, 57709 |
North Central Cancer Treatment Group |
National Cancer Institute (NCI) |
Study Chair: | Scott Okuno, MD | Mayo Clinic |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000066687, NCCTG-969257, NCI-P98-0136 |
First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003610 |
Health Authority: | United States: Federal Government |
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