Pilocarpine in Preventing Mucositis and Dry Mouth in Patients Receiving Radiation Therapy for Head and Neck Cancer
Head and Neck Cancer, Oral Complications
About this trial
This is an interventional supportive care trial for Head and Neck Cancer focused on measuring oral complications, lip and oral cavity squamous cell carcinoma, oropharyngeal squamous cell carcinoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven oral cavity and/or oropharyngeal squamous cell carcinoma Radiation volume to encompass at least 50% of parotid glands and have at least 50 Gy delivered to that volume via external beam No salivary gland malignancies or diseases PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: Karnofsky 60-100% Life Expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Effective contraceptive method must be used during study No pilocarpine allergy PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to head or neck Surgery: Not specified Other: No concurrent adrenergic antagonists, cholinergic drugs, anti-cholinergics, or tricyclics
Sites / Locations
- Veterans Affairs Medical Center - Birmingham
- University of Alabama Comprehensive Cancer Center
- Huntsville Hospital System
- Urology Associates - Mobile AL
- MBCCOP - University of South Alabama
- Alabama Oncology, LLC
- Radiation Oncology Associates of West Alabama
- Providence Cancer Therapy Center
- Arizona Cancer Center
- Providence Saint Joseph Medical Center - Burbank
- Mount Diablo Medical Center
- Beckman Research Institute, City of Hope
- California Cancer Center
- Saint Agnes Cancer Center
- Glendale Memorial Hospital and Health Center
- Sutter Health Western Division Cancer Research Group
- Loma Linda University Medical Center
- Veterans Affairs Medical Center - Long Beach
- Kaiser Permanente Medical Center - Los Angeles
- USC/Norris Comprehensive Cancer Center
- Jonsson Comprehensive Cancer Center, UCLA
- Veterans Affairs Outpatient Clinic - Martinez
- CCOP - Bay Area Tumor Institute
- Cancer Care Center
- Mercy Medical Center - Redding
- Radiation Oncology Center - Sacramento
- UCSF Cancer Center and Cancer Research Institute
- Santa Cruz Radiation Oncology Medical Group, Inc.
- CCOP - Santa Rosa Memorial Hospital
- Stanford University
- David Grant Medical Center
- Radiation Oncology Center - Walnut Creek
- Memorial Hospital Cancer Center
- University of Colorado Cancer Center
- Bridgeport Hospital
- Whittingham Cancer Center
- CCOP - Christiana Care Health Services
- Walter Reed Army Medical Center
- Lykes Center for Radiation Therapy
- Halifax Medical Center
- Radiation Therapy Associates - Fort Myers
- University of Florida Health Science Center
- Health First Holmes Regional Medical Center
- CCOP - Mount Sinai Medical Center
- Sylvester Cancer Center, University of Miami
- Baptist Hospital of Miami
- Florida Radiation Oncology Group
- MD Anderson Cancer Center Orlando
- Gulf Coast Cancer Treatment Center
- West Florida Cancer Institute - Pensacola
- Bayfront Medical Center
- H. Lee Moffitt Cancer Center and Research Institute
- Emory University Hospital - Atlanta
- CCOP - Atlanta Regional
- InterCommunity Cancer Center at Rome
- South Georgia Medical Center
- Northwestern Memorial Hospital
- University of Chicago Cancer Research Center
- Ingalls Memorial Hospital
- Loyola University Medical Center
- Lutheran General Cancer Care Center
- Methodist Medical Center of Illinois
- CCOP - Central Illinois
- CCOP - Carle Cancer Center
- St. John's Medical Center
- Clarion Health Partners Inc.
- Community Hospitals of Indianapolis - Regional Cancer Center
- Ball Memorial Hospital
- Memorial Hospital of South Bend
- St. Joseph's Radiation Oncology Center
- Wendt Regional Cancer Center of Finley Hospital
- University of Iowa Hospitals and Clinics
- Medical Center at Bowling Green
- Veterans Affairs Medical Center - Lexington
- Albert B. Chandler Medical Center, University of Kentucky
- James Graham Brown Cancer Center
- Louisville Radiation Oncology
- Merle M. Mahr Cancer Center
- Western Baptist Hospital
- Mary Bird Perkins Cancer Center
- Romagosa Radiation Oncology Center
- East Jefferson General Hospital
- MBCCOP - LSU Medical Center
- CCOP - Ochsner
- Maine Medical Center
- Anne Arundel Oncology Center
- Marlene & Stewart Greenebaum Cancer Center, University of Maryland
- Greater Baltimore Medical Center and Cancer Center
- Harbor Hospital Center
- Radiation Oncology Affiliates of Maryland, P.A.
- Johns Hopkins Oncology Center
- Massachusetts General Hospital Cancer Center
- Joint Center for Radiation Therapy
- Cape Cod Hospital
- Veterans Affairs Medical Center - Ann Arbor
- CCOP - Ann Arbor Regional
- University of Michigan Comprehensive Cancer Center
- Barbara Ann Karmanos Cancer Institute
- Henry Ford Hospital
- Hurley Medical Center
- CCOP - Kalamazoo
- Marquette General Hospital
- St. Mary's Medical Center
- Mayo Clinic Cancer Center
- CCOP - Metro-Minnesota
- Ellis Fischel Cancer Center - Columbia
- CCOP - Kansas City
- Veterans Affairs Medical Center - Saint Louis
- St. Louis University Health Sciences Center
- Mallinckrodt Institute of Radiology
- Cancer Research for the Ozarks
- CCOP - Ozarks Regional
- CCOP - Montana Cancer Consortium
- Methodist Cancer Center - Omaha
- CCOP - Missouri Valley Cancer Consortium
- CCOP - Southern Nevada Cancer Research Foundation
- Norris Cotton Cancer Center
- Elliot Regional Cancer Center
- Veterans Affairs Medical Center - East Orange
- John F. Kennedy Medical Center
- Elizabeth General Medical Center - West
- South Jersey Hospital - Millville
- Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County
- Community Medical Center
- St. Francis Medical Center
- Saint Joseph Medical Center
- Cancer Center of Albany Medical Center
- Veterans Affairs Medical Center - Albany
- Albert Einstein Comprehensive Cancer Center
- State University of New York Health Science Center at Brooklyn
- New York Methodist Hospital
- CCOP - North Shore University Hospital
- Kaplan Cancer Center
- Memorial Sloan-Kettering Cancer Center
- Champlain Valley Physicians Hospital Medical Center
- Vassar Brothers Hospital
- Genesee Hospital - Rochester
- University of Rochester Cancer Center
- New York Medical College
- Lineberger Comprehensive Cancer Center, UNC
- East Carolina University School of Medicine
- CCOP - Southeast Cancer Control Consortium
- Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
- Meritcare Roger Maris Cancer Center
- UNI-MED Medical Center
- Akron General Medical Center
- Akron City Hospital
- Christ Hospital
- Ireland Cancer Center
- CCOP - Columbus
- Arthur G. James Cancer Hospital - Ohio State University
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- CCOP - Toledo Community Hospital Oncology Program
- St. John Medical Center
- Samaritan Regional Cancer Center
- CCOP - Columbia River Program
- Penn State Geisinger Medical Center
- Mercy Catholic Medical Center, Mercy Fitzgerald Divison
- Delaware County Memorial Hospital
- Penn State Geisinger Cancer Center
- Allegheny University Hospitals- Hahnemann
- University of Pennsylvania Cancer Center
- Veterans Affairs Medical Center - Philadelphia
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
- Fox Chase Cancer Center
- Albert Einstein Cancer Center
- University of Pittsburgh Cancer Institute
- Western Pennsylvania Hospital
- Reading Hospital and Medical Center
- Mercy Hospital Cancer Center - Scranton
- Grand View Hospital
- Wilkes Barre General Hospital
- CCOP - MainLine Health
- York Hospital
- Medical University of South Carolina
- CCOP - Greenville
- CCOP - Upstate Carolina
- Jackson-Madison County General Hospital
- Baptist Regional Cancer Center - Knoxville
- CCOP - Baptist Cancer Institute
- University of Tennessee, Memphis Cancer Center
- Vanderbilt Cancer Center
- Julie and Ben Rogers Cancer Institute
- University of Texas Medical Branch
- University of Texas - MD Anderson Cancer Center
- Wilford Hall - 59th Medical Wing
- Bayshore Medical Center
- Dixie Regional Medical Center
- LDS Hospital
- CCOP - Southwestern Vermont Regional Cancer Center
- Green Mountain Oncology Group
- Veterans Affairs Medical Center - White River Junction
- Martha Jefferson Hospital
- Cancer Center, University of Virginia HSC
- Virginia Baptist Hospital
- Naval Medical Center, Portsmouth
- Massey Cancer Center
- Swedish Hospital Tumor Institute
- Virginia Mason Medical Center
- Deaconess Medical Center
- Yakima Valley Memorial Hospital
- Schiffler Oncology Center
- St. Vincent Hospital
- Gundersen Lutheran Medical Foundation
- Veterans Affairs Medical Center - Madison
- Southern Wisconsin Radiotherapy Center
- University of Wisconsin Comprehensive Cancer Center
- Marshfield Clinic
- Community Memorial Hospital
- St. Joseph's Hospital
- Columbia Hospital
- St. Luke's Medical Center
- Medical College of Wisconsin
- Veterans Affairs Medical Center - Milwaukee (Zablocki)
- Southeastern Wisconsin Regional Cancer Center
- Tom Baker Cancer Center - Calgary
- Cross Cancer Institute
- British Columbia Cancer Agency - Vancouver Island Cancer Centre
- Doctor Leon Richard Oncology Centre
- Saint John Regional Hospital
- Nova Scotia Cancer Centre
- Cancer Care Ontario-Hamilton Regional Cancer Centre
- Kingston Regional Cancer Centre
- Cancer Care Ontario-London Regional Cancer Centre
- Ottawa Regional Cancer Centre - Civic Campus
- Northeastern Ontario Regional Cancer Centre, Sudbury
- Northwestern Ontario Regional Cancer Centre, Thunder Bay
- Princess Margaret Hospital
- McGill University Department of Oncology
- Centre Hospitalier de l'Universite de Montreal
- Saskatoon Cancer Centre
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Pilocarpine hydrocloride
Placebo
5mg pilocarpine hydrochloride tablets commencing 3 days prior to irradiation
Placebo tablets commencing 3 days prior to irradiation