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 Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
Medical College of Georgia Hospital and Clinics
🇺🇸Augusta, Georgia, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Baylor College of Dentistry
🇺🇸Dallas, Texas, United States
Eye and Ear Institute
🇺🇸Pittsburgh, Pennsylvania, United States
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸San Diego, California, United States
Innovative Medical Research of South Florida, Inc.
🇺🇸Miami, Florida, United States
Ear, Nose, and Throat Specialty Care of Minnesota, P.A.
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota School of Dentistry
🇺🇸Minneapolis, Minnesota, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
State University of New York at Stony Brook School of Medicine
🇺🇸Stony Brook, New York, United States
Albert Einstein Clinical Cancer Center
🇺🇸Bronx, New York, United States
Professional Otolaryngology Associates
🇺🇸Voorhees, New Jersey, United States
Monmouth Medical Center
🇺🇸Long Branch, New Jersey, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
NYU - David B. Kriser Dental Center
🇺🇸New York, New York, United States
Head and Neck Associates
🇺🇸Havertown, Pennsylvania, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Siteman Cancer Center
🇺🇸Saint Louis, Missouri, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
Mount Sinai Medical Center, NY
🇺🇸New York, New York, United States
Latter Day Saints Hospital
🇺🇸Salt Lake City, Utah, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Dial Research Associates, Inc.
🇺🇸Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
University of Missouri
🇺🇸Columbia, Missouri, United States
State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Radiation Oncology Center - Sacramento
🇺🇸Sacramento, California, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Clinical Research of Winston Salem
🇺🇸Winston-Salem, North Carolina, United States
Oregon Cancer Institute
🇺🇸Portland, Oregon, United States
Alta Bates Comprehensive Cancer Center
🇺🇸Berkeley, California, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, 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
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Colorado Otolaryngology Associates
🇺🇸Colorado Springs, Colorado, United States
Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Kootenai Medical Center
🇺🇸Coeur d'Alene, Idaho, United States
Central Baptist Hospital
🇺🇸Lexington, Kentucky, United States
Evanston Northwestern Health Care
🇺🇸Evanston, Illinois, United States
Harbor Hospital Center
🇺🇸Baltimore, Maryland, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
James P. Wilmot Cancer Center
🇺🇸Rochester, New York, United States
Comprehensive Cancer Center at Gaston Memorial
🇺🇸Gastonia, North Carolina, United States
Matthews Radiation Oncology Center
🇺🇸Matthews, North Carolina, United States
Associated Otolaryngologist
🇺🇸Palmyra, Pennsylvania, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Memorial Hospital Cancer Center - Chattanooga
🇺🇸Chattanooga, Tennessee, United States
MultiSpecialty Clinical Research
🇺🇸Johnson City, Tennessee, United States
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States
Southwest Washington Medical Center
🇺🇸Vancouver, Washington, United States
Cancer Physicians Associates, PA
🇺🇸Laredo, Texas, United States
Seattle Institute for Biomedical and Clinical Research
🇺🇸Seattle, Washington, United States
James Graham Brown Cancer Center
🇺🇸Louisville, Kentucky, United States
Tulane Cancer Center
🇺🇸New Orleans, Louisiana, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States