Pilocarpine in Preventing Mucositis and Dry Mouth in Patients Receiving Radiation Therapy for Head and Neck Cancer
- Conditions
- Oral ComplicationsHead and Neck Cancer
- Interventions
- Other: Placebo
- Registration Number
- NCT00003139
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as pilocarpine may protect normal cells from the side effects of radiation therapy. It is not yet known if pilocarpine may be effective in preventing mucositis and dry mouth in patients receiving radiation therapy for head and neck cancer.
PURPOSE: Randomized, double-blinded, phase III trial to study the effectiveness of pilocarpine in preventing mucositis and dry mouth in patients receiving radiation therapy for head and neck cancer.
- Detailed Description
OBJECTIVES: I. Determine whether prophylactic use of pilocarpine can shelter unstimulated and stimulated whole salivary flow in patients with head and neck cancer. II. Determine whether prophylactic use of pilocarpine can moderate xerostomia in these patients. III. Determine whether prophylactic use of pilocarpine can reduce the grade and duration of radiation induced mucositis in these patients. IV. Evaluate quality of life outcomes between patients receiving pilocarpine versus placebo. V. Evaluate the impact of xerostomia on patients receiving irradiation to the head and neck.
OUTLINE: This is a randomized, double blind study. Patients receive a central axis midplane dose of radiotherapy five days per week over 6 to 7 weeks. Oral pilocarpine or placebo is administered beginning 3 days prior to radiotherapy, one tablet four times per day for three months. A tablet will be taken 45-60 minutes before radiotherapy. After three months, and after a 3-4 day rest period, all patients receive non blinded pilocarpine for an additional three month period. Patients are followed at weeks 4, 13, and 26 after the start of radiotherapy.
PROJECTED ACCRUAL: A total of 244 patients will be accrued (122 per treatment arm).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 249
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo tablets commencing 3 days prior to irradiation Pilocarpine hydrocloride pilocarpine hydrochloride 5mg pilocarpine hydrochloride tablets commencing 3 days prior to irradiation
- Primary Outcome Measures
Name Time Method Acute salivary gland toxicity From the start of treatment to 13 weeks
- Secondary Outcome Measures
Name Time Method Acute mucositis in the pharynx, palate, tongue, or buccal From the start of treatment to 13 weeks Quality of life as measured by the University of Washington Head and Neck Symptom questionnaire Pretreatment to 26 weeks from the start of treatment Effects of continuing pilocarpine out to 6 months from the start of treatment From the start of treatment to 26 weeks
Trial Locations
- Locations (232)
Anne Arundel Oncology Center
πΊπΈAnnapolis, Maryland, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
πΊπΈBaltimore, Maryland, United States
Greater Baltimore Medical Center and Cancer Center
πΊπΈBaltimore, Maryland, United States
Johns Hopkins Oncology Center
πΊπΈBaltimore, Maryland, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
πΊπΈPhiladelphia, Pennsylvania, United States
Saint John Regional Hospital
π¨π¦Saint John, New Brunswick, Canada
Northwestern Memorial Hospital
πΊπΈChicago, Illinois, United States
University of Pittsburgh Cancer Institute
πΊπΈPittsburgh, Pennsylvania, United States
Western Pennsylvania Hospital
πΊπΈPittsburgh, Pennsylvania, United States
MBCCOP - University of South Alabama
πΊπΈMobile, Alabama, United States
Veterans Affairs Medical Center - Long Beach
πΊπΈLong Beach, California, United States
Sutter Health Western Division Cancer Research Group
πΊπΈGreenbrae, California, United States
USC/Norris Comprehensive Cancer Center
πΊπΈLos Angeles, California, United States
Santa Cruz Radiation Oncology Medical Group, Inc.
πΊπΈSanta Cruz, California, United States
David Grant Medical Center
πΊπΈTravis Air Force Base, California, United States
Radiation Oncology Center - Walnut Creek
πΊπΈWalnut Creek, California, United States
Health First Holmes Regional Medical Center
πΊπΈMelbourne, Florida, United States
Baptist Hospital of Miami
πΊπΈMiami, Florida, United States
Florida Radiation Oncology Group
πΊπΈOrange Park, Florida, United States
Bayfront Medical Center
πΊπΈSaint Petersburg, Florida, United States
Gulf Coast Cancer Treatment Center
πΊπΈPanama City, Florida, United States
Ingalls Memorial Hospital
πΊπΈHarvey, Illinois, United States
University of Chicago Cancer Research Center
πΊπΈChicago, Illinois, United States
Methodist Medical Center of Illinois
πΊπΈPeoria, Illinois, United States
CCOP - Carle Cancer Center
πΊπΈUrbana, Illinois, United States
Joint Center for Radiation Therapy
πΊπΈBoston, Massachusetts, United States
Radiation Oncology Affiliates of Maryland, P.A.
πΊπΈBaltimore, Maryland, United States
MBCCOP - LSU Medical Center
πΊπΈNew Orleans, Louisiana, United States
CCOP - Kansas City
πΊπΈKansas City, Missouri, United States
CCOP - Metro-Minnesota
πΊπΈSaint Louis Park, Minnesota, United States
Marquette General Hospital
πΊπΈMarquette, Michigan, United States
CCOP - Kalamazoo
πΊπΈKalamazoo, Michigan, United States
State University of New York Health Science Center at Brooklyn
πΊπΈBrooklyn, New York, United States
Community Medical Center
πΊπΈToms River, New Jersey, United States
Kaplan Cancer Center
πΊπΈNew York, New York, United States
Vassar Brothers Hospital
πΊπΈPoughkeepsie, New York, United States
Lineberger Comprehensive Cancer Center, UNC
πΊπΈChapel Hill, North Carolina, United States
Akron General Medical Center
πΊπΈAkron, Ohio, United States
CCOP - Dayton
πΊπΈKettering, Ohio, United States
St. John Medical Center
πΊπΈTulsa, Oklahoma, United States
Mercy Catholic Medical Center, Mercy Fitzgerald Divison
πΊπΈDarby, Pennsylvania, United States
CCOP - MainLine Health
πΊπΈWynnewood, Pennsylvania, United States
Grand View Hospital
πΊπΈSellersville, Pennsylvania, United States
Wilkes Barre General Hospital
πΊπΈWilkes-Barre, Pennsylvania, United States
Julie and Ben Rogers Cancer Institute
πΊπΈBeaumont, Texas, United States
University of Texas Medical Branch
πΊπΈGalveston, Texas, United States
University of Texas - MD Anderson Cancer Center
πΊπΈHouston, Texas, United States
Bayshore Medical Center
πΊπΈPasadena, Texas, United States
Cancer Center, University of Virginia HSC
πΊπΈCharlottesville, Virginia, United States
Southern Wisconsin Radiotherapy Center
πΊπΈMadison, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center
πΊπΈMadison, Wisconsin, United States
Ottawa Regional Cancer Centre - Civic Campus
π¨π¦Ottawa, Ontario, Canada
Tom Baker Cancer Center - Calgary
π¨π¦Calgary, Alberta, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
π¨π¦Thunder Bay, Ontario, Canada
Kingston Regional Cancer Centre
π¨π¦Kingston, Ontario, Canada
UNI-MED Medical Center
πΊπΈMinot, North Dakota, United States
UCSF Cancer Center and Cancer Research Institute
πΊπΈSan Francisco, California, United States
LDS Hospital
πΊπΈSalt Lake City, Utah, United States
Mary Bird Perkins Cancer Center
πΊπΈBaton Rouge, Louisiana, United States
Centre Hospitalier de l'Universite de Montreal
π¨π¦Montreal, Quebec, Canada
CCOP - Ochsner
πΊπΈNew Orleans, Louisiana, United States
University of Tennessee, Memphis Cancer Center
πΊπΈMemphis, Tennessee, United States
Romagosa Radiation Oncology Center
πΊπΈLafayette, Louisiana, United States
Maine Medical Center
πΊπΈPortland, Maine, United States
CCOP - Baptist Cancer Institute
πΊπΈMemphis, Tennessee, United States
St. Francis Medical Center
πΊπΈTrenton, New Jersey, United States
Baptist Regional Cancer Center - Knoxville
πΊπΈKnoxville, Tennessee, United States
CCOP - Upstate Carolina
πΊπΈSpartanburg, South Carolina, United States
Elliot Regional Cancer Center
πΊπΈManchester, New Hampshire, United States
Veterans Affairs Medical Center - White River Junction
πΊπΈWhite River Junction, Vermont, United States
British Columbia Cancer Agency - Vancouver Island Cancer Centre
π¨π¦Victoria, British Columbia, Canada
Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County
πΊπΈMount Holly, New Jersey, United States
Schiffler Oncology Center
πΊπΈWheeling, West Virginia, United States
Veterans Affairs Medical Center - Birmingham
πΊπΈBirmingham, Alabama, United States
University of Alabama Comprehensive Cancer Center
πΊπΈBirmingham, Alabama, United States
Barbara Ann Karmanos Cancer Institute
πΊπΈDetroit, Michigan, United States
CCOP - Columbia River Program
πΊπΈPortland, Oregon, United States
Green Mountain Oncology Group
πΊπΈRutland, Vermont, United States
Bridgeport Hospital
πΊπΈBridgeport, Connecticut, United States
University of Florida Health Science Center
πΊπΈGainesville, Florida, United States
Kaiser Permanente Medical Center - Los Angeles
πΊπΈLos Angeles, California, United States
Veterans Affairs Outpatient Clinic - Martinez
πΊπΈMartinez, California, United States
CCOP - Mount Sinai Medical Center
πΊπΈMiami Beach, Florida, United States
Mercy Medical Center - Redding
πΊπΈRedding, California, United States
Arizona Cancer Center
πΊπΈTucson, Arizona, United States
Huntsville Hospital System
πΊπΈHuntsville, Alabama, United States
California Cancer Center
πΊπΈFresno, California, United States
Urology Associates - Mobile AL
πΊπΈMobile, Alabama, United States
Providence Cancer Therapy Center
πΊπΈAnchorage, Alaska, United States
Jonsson Comprehensive Cancer Center, UCLA
πΊπΈLos Angeles, California, United States
Mount Diablo Medical Center
πΊπΈConcord, California, United States
Providence Saint Joseph Medical Center - Burbank
πΊπΈBurbank, California, United States
Glendale Memorial Hospital and Health Center
πΊπΈGlendale, California, United States
Alabama Oncology, LLC
πΊπΈMontgomery, Alabama, United States
Radiation Oncology Associates of West Alabama
πΊπΈTuscallosa, Alabama, United States
Beckman Research Institute, City of Hope
πΊπΈDuarte, California, United States
CCOP - Bay Area Tumor Institute
πΊπΈOakland, California, United States
Loma Linda University Medical Center
πΊπΈLoma Linda, California, United States
University of Colorado Cancer Center
πΊπΈDenver, Colorado, United States
Walter Reed Army Medical Center
πΊπΈWashington, District of Columbia, United States
Memorial Hospital Cancer Center
πΊπΈColorado Springs, Colorado, United States
Whittingham Cancer Center
πΊπΈNorwalk, Connecticut, United States
CCOP - Atlanta Regional
πΊπΈAtlanta, Georgia, United States
Sylvester Cancer Center, University of Miami
πΊπΈMiami, Florida, United States
CCOP - Christiana Care Health Services
πΊπΈWilmington, Delaware, United States
St. John's Medical Center
πΊπΈAnderson, Indiana, United States
Lykes Center for Radiation Therapy
πΊπΈClearwater, Florida, United States
Emory University Hospital - Atlanta
πΊπΈAtlanta, Georgia, United States
MD Anderson Cancer Center Orlando
πΊπΈOrlando, Florida, United States
CCOP - Central Illinois
πΊπΈSpringfield, Illinois, United States
West Florida Cancer Institute - Pensacola
πΊπΈPensacola, Florida, United States
South Georgia Medical Center
πΊπΈValdosta, Georgia, United States
Clarion Health Partners Inc.
πΊπΈIndianapolis, Indiana, United States
Lutheran General Cancer Care Center
πΊπΈPark Ridge, Illinois, United States
Ball Memorial Hospital
πΊπΈMuncie, Indiana, United States
Wendt Regional Cancer Center of Finley Hospital
πΊπΈDubuque, Iowa, United States
Merle M. Mahr Cancer Center
πΊπΈMadisonville, Kentucky, United States
University of Iowa Hospitals and Clinics
πΊπΈIowa City, Iowa, United States
East Jefferson General Hospital
πΊπΈMetairie, Louisiana, United States
Veterans Affairs Medical Center - Lexington
πΊπΈLexington, Kentucky, United States
Harbor Hospital Center
πΊπΈBaltimore, Maryland, United States
Western Baptist Hospital
πΊπΈPaducah, Kentucky, United States
Henry Ford Hospital
πΊπΈDetroit, Michigan, United States
Cape Cod Hospital
πΊπΈHyannis, Massachusetts, United States
CCOP - Montana Cancer Consortium
πΊπΈBillings, Montana, United States
CCOP - North Shore University Hospital
πΊπΈManhasset, New York, United States
Elizabeth General Medical Center - West
πΊπΈElizabeth, New Jersey, United States
Norris Cotton Cancer Center
πΊπΈLebanon, New Hampshire, United States
CCOP - Southern Nevada Cancer Research Foundation
πΊπΈLas Vegas, Nevada, United States
Ellis Fischel Cancer Center - Columbia
πΊπΈColumbia, Missouri, United States
Ireland Cancer Center
πΊπΈCleveland, Ohio, United States
Albert Einstein Comprehensive Cancer Center
πΊπΈBronx, New York, United States
South Jersey Hospital - Millville
πΊπΈMillville, New Jersey, United States
New York Medical College
πΊπΈValhalla, New York, United States
East Carolina University School of Medicine
πΊπΈGreenville, North Carolina, United States
Allegheny University Hospitals- Hahnemann
πΊπΈPhiladelphia, Pennsylvania, United States
Saint Joseph Medical Center
πΊπΈAlbuquerque, New Mexico, United States
Christ Hospital
πΊπΈCincinnati, Ohio, United States
Memorial Sloan-Kettering Cancer Center
πΊπΈNew York, New York, United States
Veterans Affairs Medical Center - Albany
πΊπΈAlbany, New York, United States
Meritcare Roger Maris Cancer Center
πΊπΈFargo, North Dakota, United States
Cancer Center of Albany Medical Center
πΊπΈAlbany, New York, United States
CCOP - Columbus
πΊπΈColumbus, Ohio, United States
Veterans Affairs Medical Center - Dayton
πΊπΈDayton, Ohio, United States
Champlain Valley Physicians Hospital Medical Center
πΊπΈPlattsburgh, New York, United States
Arthur G. James Cancer Hospital - Ohio State University
πΊπΈColumbus, Ohio, United States
Samaritan Regional Cancer Center
πΊπΈCorvallis, Oregon, United States
Akron City Hospital
πΊπΈAkron, Ohio, United States
CCOP - Toledo Community Hospital Oncology Program
πΊπΈToledo, Ohio, United States
Albert Einstein Cancer Center
πΊπΈPhiladelphia, Pennsylvania, United States
Cross Cancer Institute
π¨π¦Edmonton, Alberta, Canada
Deaconess Medical Center
πΊπΈSpokane, Washington, United States
Northeastern Ontario Regional Cancer Centre, Sudbury
π¨π¦Sudbury, Ontario, Canada
Medical University of South Carolina
πΊπΈCharleston, South Carolina, United States
Naval Medical Center, Portsmouth
πΊπΈPortsmouth, Virginia, United States
Virginia Mason Medical Center
πΊπΈSeattle, Washington, United States
Vanderbilt Cancer Center
πΊπΈNashville, Tennessee, United States
Mercy Hospital Cancer Center - Scranton
πΊπΈScranton, Pennsylvania, United States
CCOP - Southwestern Vermont Regional Cancer Center
πΊπΈBennington, Vermont, United States
Jackson-Madison County General Hospital
πΊπΈJackson, Tennessee, United States
York Hospital
πΊπΈYork, Pennsylvania, United States
Massey Cancer Center
πΊπΈRichmond, Virginia, United States
CCOP - Greenville
πΊπΈGreenville, South Carolina, United States
Martha Jefferson Hospital
πΊπΈCharlottesville, Virginia, United States
Cancer Care Ontario-London Regional Cancer Centre
π¨π¦London, Ontario, Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
π¨π¦Hamilton, Ontario, Canada
St. Vincent Hospital
πΊπΈGreen Bay, Wisconsin, United States
Princess Margaret Hospital
π¨π¦Toronto, Ontario, Canada
Community Memorial Hospital
πΊπΈMenomonee Falls, Wisconsin, United States
Nova Scotia Cancer Centre
π¨π¦Halifax, Nova Scotia, Canada
Doctor Leon Richard Oncology Centre
π¨π¦Moncton, New Brunswick, Canada
McGill University Department of Oncology
π¨π¦Montreal, Quebec, Canada
Saskatoon Cancer Centre
π¨π¦Saskatoon, Saskatchewan, Canada
Mayo Clinic Cancer Center
πΊπΈRochester, Minnesota, United States
Methodist Cancer Center - Omaha
πΊπΈOmaha, Nebraska, United States
CCOP - Missouri Valley Cancer Consortium
πΊπΈOmaha, Nebraska, United States
St. Joseph's Hospital
πΊπΈMilwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
πΊπΈMilwaukee, Wisconsin, United States
Mallinckrodt Institute of Radiology
πΊπΈSaint Louis, Missouri, United States
Cancer Research for the Ozarks
πΊπΈSpringfield, Missouri, United States
CCOP - Ozarks Regional
πΊπΈSpringfield, Missouri, United States
Dixie Regional Medical Center
πΊπΈSaint George, Utah, United States
New York Methodist Hospital
πΊπΈBrooklyn, New York, United States
Genesee Hospital - Rochester
πΊπΈRochester, New York, United States
St. Mary's Medical Center
πΊπΈSaginaw, Michigan, United States
Hurley Medical Center
πΊπΈFlint, Michigan, United States
CCOP - Southeast Cancer Control Consortium
πΊπΈWinston-Salem, North Carolina, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
πΊπΈWinston-Salem, North Carolina, United States
H. Lee Moffitt Cancer Center and Research Institute
πΊπΈTampa, Florida, United States
Radiation Oncology Center - Sacramento
πΊπΈSacramento, California, United States
Radiation Therapy Associates - Fort Myers
πΊπΈFort Myers, Florida, United States
Veterans Affairs Medical Center - Ann Arbor
πΊπΈAnn Arbor, Michigan, United States
CCOP - Ann Arbor Regional
πΊπΈAnn Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
πΊπΈAnn Arbor, Michigan, United States
Saint Agnes Cancer Center
πΊπΈFresno, California, United States
Stanford University
πΊπΈStanford, California, United States
Cancer Care Center
πΊπΈPomona, California, United States
InterCommunity Cancer Center at Rome
πΊπΈRome, Georgia, United States
St. Joseph's Radiation Oncology Center
πΊπΈSouth Bend, Indiana, United States
Community Hospitals of Indianapolis - Regional Cancer Center
πΊπΈIndianapolis, Indiana, United States
Memorial Hospital of South Bend
πΊπΈSouth Bend, Indiana, United States
Albert B. Chandler Medical Center, University of Kentucky
πΊπΈLexington, Kentucky, United States
James Graham Brown Cancer Center
πΊπΈLouisville, Kentucky, United States
Medical Center at Bowling Green
πΊπΈBowling Green, Kentucky, United States
Massachusetts General Hospital Cancer Center
πΊπΈBoston, Massachusetts, United States
Penn State Geisinger Medical Center
πΊπΈDanville, Pennsylvania, United States
University of Pennsylvania Cancer Center
πΊπΈPhiladelphia, Pennsylvania, United States
Fox Chase Cancer Center
πΊπΈPhiladelphia, Pennsylvania, United States
Penn State Geisinger Cancer Center
πΊπΈHershey, Pennsylvania, United States
Reading Hospital and Medical Center
πΊπΈReading, Pennsylvania, United States
Wilford Hall - 59th Medical Wing
πΊπΈLackland Air Force Base, Texas, United States
Virginia Baptist Hospital
πΊπΈLynchburg, Virginia, United States
Veterans Affairs Medical Center - Madison
πΊπΈMadison, Wisconsin, United States
Marshfield Clinic
πΊπΈMarshfield, Wisconsin, United States
Swedish Hospital Tumor Institute
πΊπΈSeattle, Washington, United States
Yakima Valley Memorial Hospital
πΊπΈYakima, Washington, United States
Columbia Hospital
πΊπΈMilwaukee, Wisconsin, United States
St. Luke's Medical Center
πΊπΈMilwaukee, Wisconsin, United States
Medical College of Wisconsin
πΊπΈMilwaukee, Wisconsin, United States
Southeastern Wisconsin Regional Cancer Center
πΊπΈRacine, Wisconsin, United States
CCOP - Santa Rosa Memorial Hospital
πΊπΈSanta Rosa, California, United States
Veterans Affairs Medical Center - Saint Louis
πΊπΈSaint Louis, Missouri, United States
Louisville Radiation Oncology
πΊπΈLouisville, Kentucky, United States
Loyola University Medical Center
πΊπΈMaywood, Illinois, United States
Delaware County Memorial Hospital
πΊπΈDrexel Hill, Pennsylvania, United States
St. Louis University Health Sciences Center
πΊπΈSaint Louis, Missouri, United States
Veterans Affairs Medical Center - Philadelphia
πΊπΈPhiladelphia, Pennsylvania, United States
Gundersen Lutheran Medical Foundation
πΊπΈLa Crosse, Wisconsin, United States
University of Rochester Cancer Center
πΊπΈRochester, New York, United States
Halifax Medical Center
πΊπΈDaytona Beach, Florida, United States
Veterans Affairs Medical Center - East Orange
πΊπΈEast Orange, New Jersey, United States
John F. Kennedy Medical Center
πΊπΈEdison, New Jersey, United States