Spots Global Cancer Trial Database for Pilocarpine in Preventing Mucositis and Dry Mouth in Patients Receiving Radiation Therapy for Head and Neck Cancer
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Trial Identification
Brief Title: Pilocarpine in Preventing Mucositis and Dry Mouth in Patients Receiving Radiation Therapy for Head and Neck Cancer
Official Title: A Phase III Study to Test the Efficacy of the Prophylactic Use of Oral Pilocarpine to Reduce Hyposalivation and Mucositis Associated With Curative Radiation Therapy in Head and Neck Cancer Patients
Study ID: NCT00003139
Study Description
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).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Veterans Affairs Medical Center - Birmingham, Birmingham, Alabama, United States
University of Alabama Comprehensive Cancer Center, Birmingham, Alabama, United States
Huntsville Hospital System, Huntsville, Alabama, United States
Urology Associates - Mobile AL, Mobile, Alabama, United States
MBCCOP - University of South Alabama, Mobile, Alabama, United States
Alabama Oncology, LLC, Montgomery, Alabama, United States
Radiation Oncology Associates of West Alabama, Tuscallosa, Alabama, United States
Providence Cancer Therapy Center, Anchorage, Alaska, United States
Arizona Cancer Center, Tucson, Arizona, United States
Providence Saint Joseph Medical Center - Burbank, Burbank, California, United States
Mount Diablo Medical Center, Concord, California, United States
Beckman Research Institute, City of Hope, Duarte, California, United States
California Cancer Center, Fresno, California, United States
Saint Agnes Cancer Center, Fresno, California, United States
Glendale Memorial Hospital and Health Center, Glendale, California, United States
Sutter Health Western Division Cancer Research Group, Greenbrae, California, United States
Loma Linda University Medical Center, Loma Linda, California, United States
Veterans Affairs Medical Center - Long Beach, Long Beach, California, United States
Kaiser Permanente Medical Center - Los Angeles, Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
Veterans Affairs Outpatient Clinic - Martinez, Martinez, California, United States
CCOP - Bay Area Tumor Institute, Oakland, California, United States
Cancer Care Center, Pomona, California, United States
Mercy Medical Center - Redding, Redding, California, United States
Radiation Oncology Center - Sacramento, Sacramento, California, United States
UCSF Cancer Center and Cancer Research Institute, San Francisco, California, United States
Santa Cruz Radiation Oncology Medical Group, Inc., Santa Cruz, California, United States
CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California, United States
Stanford University, Stanford, California, United States
David Grant Medical Center, Travis Air Force Base, California, United States
Radiation Oncology Center - Walnut Creek, Walnut Creek, California, United States
Memorial Hospital Cancer Center, Colorado Springs, Colorado, United States
University of Colorado Cancer Center, Denver, Colorado, United States
Bridgeport Hospital, Bridgeport, Connecticut, United States
Whittingham Cancer Center, Norwalk, Connecticut, United States
CCOP - Christiana Care Health Services, Wilmington, Delaware, United States
Walter Reed Army Medical Center, Washington, District of Columbia, United States
Lykes Center for Radiation Therapy, Clearwater, Florida, United States
Halifax Medical Center, Daytona Beach, Florida, United States
Radiation Therapy Associates - Fort Myers, Fort Myers, Florida, United States
University of Florida Health Science Center, Gainesville, Florida, United States
Health First Holmes Regional Medical Center, Melbourne, Florida, United States
CCOP - Mount Sinai Medical Center, Miami Beach, Florida, United States
Sylvester Cancer Center, University of Miami, Miami, Florida, United States
Baptist Hospital of Miami, Miami, Florida, United States
Florida Radiation Oncology Group, Orange Park, Florida, United States
MD Anderson Cancer Center Orlando, Orlando, Florida, United States
Gulf Coast Cancer Treatment Center, Panama City, Florida, United States
West Florida Cancer Institute - Pensacola, Pensacola, Florida, United States
Bayfront Medical Center, Saint Petersburg, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Emory University Hospital - Atlanta, Atlanta, Georgia, United States
CCOP - Atlanta Regional, Atlanta, Georgia, United States
InterCommunity Cancer Center at Rome, Rome, Georgia, United States
South Georgia Medical Center, Valdosta, Georgia, United States
Northwestern Memorial Hospital, Chicago, Illinois, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Ingalls Memorial Hospital, Harvey, Illinois, United States
Loyola University Medical Center, Maywood, Illinois, United States
Lutheran General Cancer Care Center, Park Ridge, Illinois, United States
Methodist Medical Center of Illinois, Peoria, Illinois, United States
CCOP - Central Illinois, Springfield, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
St. John's Medical Center, Anderson, Indiana, United States
Clarion Health Partners Inc., Indianapolis, Indiana, United States
Community Hospitals of Indianapolis - Regional Cancer Center, Indianapolis, Indiana, United States
Ball Memorial Hospital, Muncie, Indiana, United States
Memorial Hospital of South Bend, South Bend, Indiana, United States
St. Joseph's Radiation Oncology Center, South Bend, Indiana, United States
Wendt Regional Cancer Center of Finley Hospital, Dubuque, Iowa, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
Medical Center at Bowling Green, Bowling Green, Kentucky, United States
Veterans Affairs Medical Center - Lexington, Lexington, Kentucky, United States
Albert B. Chandler Medical Center, University of Kentucky, Lexington, Kentucky, United States
James Graham Brown Cancer Center, Louisville, Kentucky, United States
Louisville Radiation Oncology, Louisville, Kentucky, United States
Merle M. Mahr Cancer Center, Madisonville, Kentucky, United States
Western Baptist Hospital, Paducah, Kentucky, United States
Mary Bird Perkins Cancer Center, Baton Rouge, Louisiana, United States
Romagosa Radiation Oncology Center, Lafayette, Louisiana, United States
East Jefferson General Hospital, Metairie, Louisiana, United States
MBCCOP - LSU Medical Center, New Orleans, Louisiana, United States
CCOP - Ochsner, New Orleans, Louisiana, United States
Maine Medical Center, Portland, Maine, United States
Anne Arundel Oncology Center, Annapolis, Maryland, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland, United States
Greater Baltimore Medical Center and Cancer Center, Baltimore, Maryland, United States
Harbor Hospital Center, Baltimore, Maryland, United States
Radiation Oncology Affiliates of Maryland, P.A., Baltimore, Maryland, United States
Johns Hopkins Oncology Center, Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Joint Center for Radiation Therapy, Boston, Massachusetts, United States
Cape Cod Hospital, Hyannis, Massachusetts, United States
Veterans Affairs Medical Center - Ann Arbor, Ann Arbor, Michigan, United States
CCOP - Ann Arbor Regional, Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Henry Ford Hospital, Detroit, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
CCOP - Kalamazoo, Kalamazoo, Michigan, United States
Marquette General Hospital, Marquette, Michigan, United States
St. Mary's Medical Center, Saginaw, Michigan, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States
Ellis Fischel Cancer Center - Columbia, Columbia, Missouri, United States
CCOP - Kansas City, Kansas City, Missouri, United States
Veterans Affairs Medical Center - Saint Louis, Saint Louis, Missouri, United States
St. Louis University Health Sciences Center, Saint Louis, Missouri, United States
Mallinckrodt Institute of Radiology, Saint Louis, Missouri, United States
Cancer Research for the Ozarks, Springfield, Missouri, United States
CCOP - Ozarks Regional, Springfield, Missouri, United States
CCOP - Montana Cancer Consortium, Billings, Montana, United States
Methodist Cancer Center - Omaha, Omaha, Nebraska, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
Norris Cotton Cancer Center, Lebanon, New Hampshire, United States
Elliot Regional Cancer Center, Manchester, New Hampshire, United States
Veterans Affairs Medical Center - East Orange, East Orange, New Jersey, United States
John F. Kennedy Medical Center, Edison, New Jersey, United States
Elizabeth General Medical Center - West, Elizabeth, New Jersey, United States
South Jersey Hospital - Millville, Millville, New Jersey, United States
Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County, Mount Holly, New Jersey, United States
Community Medical Center, Toms River, New Jersey, United States
St. Francis Medical Center, Trenton, New Jersey, United States
Saint Joseph Medical Center, Albuquerque, New Mexico, United States
Cancer Center of Albany Medical Center, Albany, New York, United States
Veterans Affairs Medical Center - Albany, Albany, New York, United States
Albert Einstein Comprehensive Cancer Center, Bronx, New York, United States
State University of New York Health Science Center at Brooklyn, Brooklyn, New York, United States
New York Methodist Hospital, Brooklyn, New York, United States
CCOP - North Shore University Hospital, Manhasset, New York, United States
Kaplan Cancer Center, New York, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Champlain Valley Physicians Hospital Medical Center, Plattsburgh, New York, United States
Vassar Brothers Hospital, Poughkeepsie, New York, United States
Genesee Hospital - Rochester, Rochester, New York, United States
University of Rochester Cancer Center, Rochester, New York, United States
New York Medical College, Valhalla, New York, United States
Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina, United States
East Carolina University School of Medicine, Greenville, North Carolina, United States
CCOP - Southeast Cancer Control Consortium, Winston-Salem, North Carolina, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina, United States
Meritcare Roger Maris Cancer Center, Fargo, North Dakota, United States
UNI-MED Medical Center, Minot, North Dakota, United States
Akron General Medical Center, Akron, Ohio, United States
Akron City Hospital, Akron, Ohio, United States
Christ Hospital, Cincinnati, Ohio, United States
Ireland Cancer Center, Cleveland, Ohio, United States
CCOP - Columbus, Columbus, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, United States
Veterans Affairs Medical Center - Dayton, Dayton, Ohio, United States
CCOP - Dayton, Kettering, Ohio, United States
CCOP - Toledo Community Hospital Oncology Program, Toledo, Ohio, United States
St. John Medical Center, Tulsa, Oklahoma, United States
Samaritan Regional Cancer Center, Corvallis, Oregon, United States
CCOP - Columbia River Program, Portland, Oregon, United States
Penn State Geisinger Medical Center, Danville, Pennsylvania, United States
Mercy Catholic Medical Center, Mercy Fitzgerald Divison, Darby, Pennsylvania, United States
Delaware County Memorial Hospital, Drexel Hill, Pennsylvania, United States
Penn State Geisinger Cancer Center, Hershey, Pennsylvania, United States
Allegheny University Hospitals- Hahnemann, Philadelphia, Pennsylvania, United States
University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, United States
Veterans Affairs Medical Center - Philadelphia, Philadelphia, Pennsylvania, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Albert Einstein Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, United States
Reading Hospital and Medical Center, Reading, Pennsylvania, United States
Mercy Hospital Cancer Center - Scranton, Scranton, Pennsylvania, United States
Grand View Hospital, Sellersville, Pennsylvania, United States
Wilkes Barre General Hospital, Wilkes-Barre, Pennsylvania, United States
CCOP - MainLine Health, Wynnewood, Pennsylvania, United States
York Hospital, York, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
CCOP - Greenville, Greenville, South Carolina, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina, United States
Jackson-Madison County General Hospital, Jackson, Tennessee, United States
Baptist Regional Cancer Center - Knoxville, Knoxville, Tennessee, United States
CCOP - Baptist Cancer Institute, Memphis, Tennessee, United States
University of Tennessee, Memphis Cancer Center, Memphis, Tennessee, United States
Vanderbilt Cancer Center, Nashville, Tennessee, United States
Julie and Ben Rogers Cancer Institute, Beaumont, Texas, United States
University of Texas Medical Branch, Galveston, Texas, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
Wilford Hall - 59th Medical Wing, Lackland Air Force Base, Texas, United States
Bayshore Medical Center, Pasadena, Texas, United States
Dixie Regional Medical Center, Saint George, Utah, United States
LDS Hospital, Salt Lake City, Utah, United States
CCOP - Southwestern Vermont Regional Cancer Center, Bennington, Vermont, United States
Green Mountain Oncology Group, Rutland, Vermont, United States
Veterans Affairs Medical Center - White River Junction, White River Junction, Vermont, United States
Martha Jefferson Hospital, Charlottesville, Virginia, United States
Cancer Center, University of Virginia HSC, Charlottesville, Virginia, United States
Virginia Baptist Hospital, Lynchburg, Virginia, United States
Naval Medical Center, Portsmouth, Portsmouth, Virginia, United States
Massey Cancer Center, Richmond, Virginia, United States
Swedish Hospital Tumor Institute, Seattle, Washington, United States
Virginia Mason Medical Center, Seattle, Washington, United States
Deaconess Medical Center, Spokane, Washington, United States
Yakima Valley Memorial Hospital, Yakima, Washington, United States
Schiffler Oncology Center, Wheeling, West Virginia, United States
St. Vincent Hospital, Green Bay, Wisconsin, United States
Gundersen Lutheran Medical Foundation, La Crosse, Wisconsin, United States
Veterans Affairs Medical Center - Madison, Madison, Wisconsin, United States
Southern Wisconsin Radiotherapy Center, Madison, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States
Marshfield Clinic, Marshfield, Wisconsin, United States
Community Memorial Hospital, Menomonee Falls, Wisconsin, United States
St. Joseph's Hospital, Milwaukee, Wisconsin, United States
Columbia Hospital, Milwaukee, Wisconsin, United States
St. Luke's Medical Center, Milwaukee, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki), Milwaukee, Wisconsin, United States
Southeastern Wisconsin Regional Cancer Center, Racine, Wisconsin, United States
Tom Baker Cancer Center - Calgary, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
British Columbia Cancer Agency - Vancouver Island Cancer Centre, Victoria, British Columbia, Canada
Doctor Leon Richard Oncology Centre, Moncton, New Brunswick, Canada
Saint John Regional Hospital, Saint John, New Brunswick, Canada
Nova Scotia Cancer Centre, Halifax, Nova Scotia, Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre, Hamilton, Ontario, Canada
Kingston Regional Cancer Centre, Kingston, Ontario, Canada
Cancer Care Ontario-London Regional Cancer Centre, London, Ontario, Canada
Ottawa Regional Cancer Centre - Civic Campus, Ottawa, Ontario, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury, Sudbury, Ontario, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay, Thunder Bay, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
McGill University Department of Oncology, Montreal, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, Canada
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada
Contact Details
Name: Francis G. LeVeque, DDS
Affiliation: Barbara Ann Karmanos Cancer Institute
Role: STUDY_CHAIR
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