Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer
NCT ID: NCT00017511
Last Updated: 2012-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
2001-06-30
2003-03-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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SUPPORTIVE_CARE
Interventions
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cevimeline hydrochloride
Eligibility Criteria
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Inclusion Criteria
* Received more than 4,000 cGy of prior external beam radiotherapy for cancer in the head and neck region
* Radiotherapy completed more than 4 months prior to study
* Clinically significant salivary gland dysfunction with grade 2 or 3 xerostomia
* At least 1 anatomically intact parotid gland
* No suspected or confirmed bilateral physical closure of salivary gland ducts
* No history of primary or secondary Sjogren's syndrome or other underlying systemic illness known to cause xerostomia independent of prior radiotherapy exposure
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 70-100%
* ECOG 0-2
Life expectancy:
* At least 6 months
Hematopoietic:
* Hemoglobin at least 9.0 g/dL
* No anemia
Hepatic:
* Bilirubin no greater than 2 times upper limit of normal (ULN)
* SGOT/SGPT no greater than 2 times ULN
* Lactate dehydrogenase no greater than 2 times ULN
* No evidence of active liver disease
Renal:
* Creatinine no greater than 2.5 mg/dL
* BUN no greater than 50 mg/dL
* No history of nephrolithiasis within the past 6 months
Cardiovascular:
* No history of significant cardiovascular disease
* No active congestive heart failure
* No uncontrolled angina
* No significant arrhythmia
* No myocardial infarction within the past 6 months
Pulmonary:
* No history of significant pulmonary disease
* No controlled or uncontrolled asthma
* No chronic bronchitis or chronic obstructive pulmonary disease that would limit avocational activities
Gastrointestinal:
* No history of significant gastrointestinal disorder
* No active pancreatic disease
* No gastroduodenal ulcers within the past 6 months
* No hypersensitive bowel conditions requiring pharmacologic therapy
* No inflammatory bowel disease
* No history of cholelithiasis within the past 6 months (unless cholecystectomy performed)
Other:
* No clinically significant laboratory abnormality
* No history of alcohol or drug abuse within the past 6 months that would preclude study
* No prior or concurrent acute iritis or narrow-angle (angle closure) glaucoma
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No concurrent chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* See Disease Characteristics
* No concurrent radiotherapy
Surgery:
* Not specified
Other:
* At least 30 days since other investigational new drug
* At least 4 weeks since prior systemic or ophthalmic pilocarpine
* No prior cevimeline
* No concurrent hyperbaric oxygen therapy
* No concurrent beta adrenergic antagonists, anticholinergic agents, cevimeline metabolism inhibitors, or other medications known to effect salivary function
* No other concurrent investigational drugs
18 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Vitti, MD
Role: STUDY_CHAIR
Daiichi Sankyo
Locations
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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
Colorado Otolaryngology Associates
Colorado Springs, Colorado, United States
University of Connecticut Health Center
Farmington, Connecticut, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Innovative Medical Research of South Florida, Inc.
Miami, Florida, United States
Medical College of Georgia Hospital and Clinics
Augusta, Georgia, United States
Kootenai Medical Center
Coeur d'Alene, Idaho, United States
University of Illinois at Chicago
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Evanston Northwestern Health Care
Evanston, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Central Baptist Hospital
Lexington, Kentucky, United States
James Graham Brown Cancer Center
Louisville, Kentucky, United States
Louisville, Kentucky, United States
Tulane Cancer Center
New Orleans, Louisiana, United States
Harbor Hospital Center
Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 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
University of Mississippi Medical Center
Jackson, Mississippi, United States
University of Missouri
Columbia, Missouri, United States
Siteman Cancer Center
St Louis, Missouri, United States
University of Nebraska Medical Center
Lincoln, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Monmouth Medical Center
Long Branch, New Jersey, United States
Professional Otolaryngology Associates
Voorhees Township, New Jersey, United States
North Shore University Hospital
Manhasset, New York, United States
NYU - David B. Kriser Dental Center
New York, New York, United States
Mount Sinai Medical Center, NY
New York, New York, United States
James P. Wilmot Cancer Center
Rochester, New York, United States
State University of New York at Stony Brook School of Medicine
Stony Brook, New York, United States
State University of New York - Upstate Medical University
Syracuse, New York, United States
Albert Einstein Clinical Cancer Center
The Bronx, New York, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Comprehensive Cancer Center at Gaston Memorial
Gastonia, North Carolina, United States
Matthews Radiation Oncology Center
Matthews, North Carolina, United States
Clinical Research of Winston Salem
Winston-Salem, North Carolina, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Oregon Cancer Institute
Portland, Oregon, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Head and Neck Associates
Havertown, Pennsylvania, United States
Associated Otolaryngologist
Palmyra, Pennsylvania, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Eye and Ear Institute
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Memorial Hospital Cancer Center - Chattanooga
Chattanooga, Tennessee, United States
MultiSpecialty Clinical Research
Johnson City, Tennessee, United States
Dial Research Associates, Inc.
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Baylor College of Dentistry
Dallas, Texas, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Cancer Physicians Associates, PA
Laredo, Texas, United States
Latter Day Saints Hospital
Salt Lake City, Utah, United States
McLean, Virginia, United States
Seattle Institute for Biomedical and Clinical Research
Seattle, Washington, United States
Madigan Army Medical Center
Tacoma, Washington, United States
Southwest Washington Medical Center
Vancouver, Washington, United States
Countries
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Other Identifiers
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DAIICHI-2011A-PRT003/004
Identifier Type: -
Identifier Source: secondary_id
UCLA-0104045
Identifier Type: -
Identifier Source: secondary_id
CDR0000068698
Identifier Type: -
Identifier Source: org_study_id
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