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Phase III Comparison of Oral Capsaicin Lozenge Versus Placebo Lozenge for Radiation-Induced Mucositis (NCT00003610)

National Cancer Institute (NCI)
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.
  • : capsaicin
    • Other: placebo
      • Radiation: radiation therapy
        Ages eligible for Study
        18 Years and older
        Genders eligible for Study
        All
        Accepts Healthy Volunteers
        No
        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.

        17 locations

        United States (17)
        • CCOP - Scottsdale Oncology Program
          Not specified
          Scottsdale, Arizona, United States, 85259-5404
        • CCOP - Illinois Oncology Research Association
          Not specified
          Peoria, Illinois, United States, 61602
        • CCOP - Carle Cancer Center
          Not specified
          Urbana, Illinois, United States, 61801
        • CCOP - Cedar Rapids Oncology Project
          Not specified
          Cedar Rapids, Iowa, United States, 52403-1206
        • CCOP - Iowa Oncology Research Association
          Not specified
          Des Moines, Iowa, United States, 10309-1016
        • Siouxland Hematology-Oncology
          Not specified
          Sioux City, Iowa, United States, 51101-1733
        • CCOP - Wichita
          Not specified
          Wichita, Kansas, United States, 67214-3882
        • CCOP - Duluth
          Not specified
          Duluth, Minnesota, United States, 55805
        • Mayo Clinic Cancer Center
          Not specified
          Rochester, Minnesota, United States, 55905
        • CentraCare Clinic
          Not specified
          Saint Cloud, Minnesota, United States, 56303
        • CCOP - Missouri Valley Cancer Consortium
          Not specified
          Omaha, Nebraska, United States, 68131
        • Quain & Ramstad Clinic, P.C.
          Not specified
          Bismarck, North Dakota, United States, 58501
        • Altru Health Systems
          Not specified
          Grand Forks, North Dakota, United States, 58201
        • CCOP - Toledo Community Hospital Oncology Program
          Not specified
          Toledo, Ohio, United States, 43623-3456
        • CCOP - Geisinger Clinical and Medical Center
          Not specified
          Danville, Pennsylvania, United States, 17822-2001
        • Rapid City Regional Hospital
          Not specified
          Rapid City, South Dakota, United States, 57709
        • CCOP - Sioux Community Cancer Consortium
          Not specified
          Sioux Falls, South Dakota, United States, 57105-1080
        Status:
        completed
        Type:
        Interventional
        Phase:
        Start:
        30 September, 1998
        Updated:
        11 July, 2016
        Participants:
        18
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