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Capsaicin Lozenges in Treating Patients With Mucositis Caused by Radiation Therapy

This study has been completed.

Sponsors and Collaborators: North Central Cancer Treatment Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003610
  Purpose

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   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care, Randomized
Official Title:   Phase III Comparison of Oral Capsaicin Lozenge Versus Placebo Lozenge for Radiation-Induced Mucositis

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   October 1998

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003610

Locations
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

Sponsors and Collaborators
North Central Cancer Treatment Group
National Cancer Institute (NCI)

Investigators
Study Chair:     Scott Okuno, MD     Mayo Clinic    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

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

Keywords provided by National Cancer Institute (NCI):
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 of cancer and cancer therapy
radiation toxicity

Study placed in the following topic categories:
Mouth Diseases
Mucositis
Gastrointestinal Diseases
Salicylsalicylic acid
Sodium Salicylate
Laryngeal Neoplasms
Capsaicin
Lip and oral cavity cancer
Digestive System Diseases
Nasopharyngeal carcinoma
Head and Neck Neoplasms
Oral cancer
Laryngeal carcinoma
Hypopharyngeal cancer
Stomatognathic Diseases
Gastroenteritis
Salivary Gland Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Antipruritics
Peripheral Nervous System Agents
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 19, 2008




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