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


Phase 3
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer, Oral Complications, Radiation Toxicity

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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