Phase III Comparison of Oral Capsaicin Lozenge Versus Placebo Lozenge for Radiation-Induced Mucositis
18 Years
N/A
Both
Head and Neck Cancer, Oral Complications, Radiation Toxicity
Trial Information
Phase III Comparison of Oral Capsaicin Lozenge Versus Placebo Lozenge for Radiation-Induced Mucositis
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Supportive Care
Principal Investigator
Scott Okuno, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000066687
NCT ID:
NCT00003610
Start Date:
October 1998
Completion Date:
Related Keywords:
- Head and Neck Cancer
- Oral Complications
- Radiation Toxicity
- stage I nasopharyngeal cancer
- stage II nasopharyngeal cancer
- stage III nasopharyngeal cancer
- stage IV nasopharyngeal cancer
- stage I salivary gland cancer
- stage II salivary gland cancer
- stage III salivary gland cancer
- stage IV salivary gland cancer
- stage I lip and oral cavity cancer
- stage II lip and oral cavity cancer
- stage III lip and oral cavity cancer
- stage IV lip and oral cavity cancer
- stage I hypopharyngeal cancer
- stage II hypopharyngeal cancer
- stage III hypopharyngeal cancer
- stage IV hypopharyngeal cancer
- stage I laryngeal cancer
- stage II laryngeal cancer
- stage III laryngeal cancer
- stage IV laryngeal cancer
- stage I paranasal sinus and nasal cavity cancer
- stage II paranasal sinus and nasal cavity cancer
- stage III paranasal sinus and nasal cavity cancer
- stage IV paranasal sinus and nasal cavity cancer
- stage I oropharyngeal cancer
- stage II oropharyngeal cancer
- stage III oropharyngeal cancer
- stage IV oropharyngeal cancer
- oral complications
- radiation toxicity
- Head and Neck Neoplasms
- Radiation Injuries
- Mucositis
Name | Location |
|---|---|
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
| CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
| CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
| CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
| CCOP - Duluth | Duluth, Minnesota 55805 |
| CCOP - Scottsdale Oncology Program | Scottsdale, Arizona 85259-5404 |
| CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
| Siouxland Hematology-Oncology | Sioux City, Iowa 51101-1733 |
| CentraCare Clinic | Saint Cloud, Minnesota 56303 |
| Quain & Ramstad Clinic, P.C. | Bismarck, North Dakota 58501 |
| Altru Health Systems | Grand Forks, North Dakota 58201 |
| CCOP - Toledo Community Hospital Oncology Program | Toledo, Ohio 43623-3456 |
| CCOP - Geisinger Clinical and Medical Center | Danville, Pennsylvania 17822-2001 |
| Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
| CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
