Capsaicin Lozenges in Treating Patients With Mucositis Caused by Radiation Therapy

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00003610
First received: November 1, 1999
Last updated: July 7, 2015
Last verified: July 2015

November 1, 1999
July 7, 2015
October 1998
July 2006   (final data collection date for primary outcome measure)
  • frequency of mouth pain [ Time Frame: Up to 2 weeks post-radiation treatment ] [ Designated as safety issue: No ]
  • duration of mouth pain [ Time Frame: Up to 2 weeks post-radiation treatment ] [ Designated as safety issue: No ]
  • severity of mouth pain [ Time Frame: Up to 2 weeks post-radiation treatment ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00003610 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Capsaicin Lozenges in Treating Patients With Mucositis Caused by Radiation Therapy
Phase III Comparison of Oral Capsaicin Lozenge Versus Placebo Lozenge for Radiation-Induced Mucositis

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
  • Head and Neck Cancer
  • Radiation Toxicity
  • Dietary Supplement: capsaicin
  • Other: placebo
  • Radiation: radiation therapy
  • Experimental: capsaicin + radiation therapy
    Patients receive one lozenge orally of capsaicin 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.
    Interventions:
    • Dietary Supplement: capsaicin
    • Radiation: radiation therapy
  • Placebo Comparator: placebo + radiation therapy
    Patients receive one lozenge orally of 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.
    Interventions:
    • Other: placebo
    • Radiation: radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
July 2006
July 2006   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003610
NCCTG-969257, CDR0000066687, NCI-P98-0136
No
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Scott Okuno, MD Mayo Clinic
Alliance for Clinical Trials in Oncology
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP