Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer
- Conditions
- Head and Neck CancerOral ComplicationsRadiation Toxicity
- Registration Number
- NCT00017511
- Lead Sponsor
- Daiichi Sankyo
- Brief Summary
RATIONALE: Cevimeline may be effective in treating dry mouth that is caused by radiation therapy for head and neck cancer. It is not yet known if cevimeline is more effective than no therapy in treating dry mouth caused by radiation therapy.
PURPOSE: Randomized phase III trial to determine the effectiveness of cevimeline in treating patients who have dryness of the mouth caused by radiation therapy for head and neck cancer.
- Detailed Description
OBJECTIVES:
* Compare the efficacy of cevimeline vs placebo, in terms of dryness of the oral cavity and salivary flow, in patients with xerostomia secondary to radiotherapy for cancers in the head and neck region.
* Assess the safety of this drug in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral cevimeline 3 times daily for 12 weeks in the absence of unacceptable toxicity.
* Arm II: Patients receive oral placebo as in arm I.
PROJECTED ACCRUAL: A total of 280 patients (140 per arm) will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (68)
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States
Cranial Pain Research
🇺🇸Tucson, Arizona, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Alta Bates Comprehensive Cancer Center
🇺🇸Berkeley, California, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
Radiation Oncology Center - Sacramento
🇺🇸Sacramento, California, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸San Diego, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Scroll for more (58 remaining)University of Alabama at Birmingham Comprehensive Cancer Center🇺🇸Birmingham, Alabama, United States