Clinical trial NCT00003139: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Head and Neck Cancer
Oral Complications
Keywords: oral complications
lip and oral cavity squamous cell carcinoma
oropharyngeal squamous cell carcinoma
Lead sponsor: Radiation Therapy Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-09-06
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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 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

Primary outcomes:
measure: Acute salivary gland toxicity
timeFrame: From the start of treatment to 13 weeks
Secondary outcomes:
measure: Acute mucositis in the pharynx, palate, tongue, or buccal
timeFrame: From the start of treatment to 13 weeks
measure: Quality of life as measured by the University of Washington Head and Neck Symptom questionnaire
timeFrame: Pretreatment to 26 weeks from the start of treatment
measure: Effects of continuing pilocarpine out to 6 months from the start of treatment
timeFrame: From the start of treatment to 26 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Veterans Affairs Medical Center - Birmingham
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama Comprehensive Cancer Center
state: Alabama
city: Huntsville
country: United States
facility: Huntsville Hospital System
state: Alabama
city: Mobile
country: United States
facility: Urology Associates - Mobile AL
state: Alabama
city: Mobile
country: United States
facility: MBCCOP - University of South Alabama
state: Alabama
city: Montgomery
country: United States
facility: Alabama Oncology, LLC
state: Alabama
city: Tuscallosa
country: United States
facility: Radiation Oncology Associates of West Alabama
state: Alabama
city: Anchorage
country: United States
facility: Providence Cancer Therapy Center
state: Alaska
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Burbank
country: United States
facility: Providence Saint Joseph Medical Center - Burbank
state: California
city: Concord
country: United States
facility: Mount Diablo Medical Center
state: California
city: Duarte
country: United States
facility: Beckman Research Institute, City of Hope
state: California
city: Fresno
country: United States
facility: California Cancer Center
state: California
city: Fresno
country: United States
facility: Saint Agnes Cancer Center
state: California
city: Glendale
country: United States
facility: Glendale Memorial Hospital and Health Center
state: California
city: Greenbrae
country: United States
facility: Sutter Health Western Division Cancer Research Group
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Long Beach
country: United States
facility: Veterans Affairs Medical Center - Long Beach
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Medical Center - Los Angeles
state: California
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center, UCLA
state: California
city: Martinez
country: United States
facility: Veterans Affairs Outpatient Clinic - Martinez
state: California
city: Oakland
country: United States
facility: CCOP - Bay Area Tumor Institute
state: California
city: Pomona
country: United States
facility: Cancer Care Center
state: California
city: Redding
country: United States
facility: Mercy Medical Center - Redding
state: California
city: Sacramento
country: United States
facility: Radiation Oncology Center - Sacramento
state: California
city: San Francisco
country: United States
facility: UCSF Cancer Center and Cancer Research Institute
state: California
city: Santa Cruz
country: United States
facility: Santa Cruz Radiation Oncology Medical Group, Inc.
state: California
city: Santa Rosa
country: United States
facility: CCOP - Santa Rosa Memorial Hospital
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Travis Air Force Base
country: United States
facility: David Grant Medical Center
state: California
city: Walnut Creek
country: United States
facility: Radiation Oncology Center - Walnut Creek
state: California
city: Colorado Springs
country: United States
facility: Memorial Hospital Cancer Center
state: Colorado
city: Denver
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Bridgeport
country: United States
facility: Bridgeport Hospital
state: Connecticut
city: Norwalk
country: United States
facility: Whittingham Cancer Center
state: Connecticut
city: Wilmington
country: United States
facility: CCOP - Christiana Care Health Services
state: Delaware
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
city: Clearwater
country: United States
facility: Lykes Center for Radiation Therapy
state: Florida
city: Daytona Beach
country: United States
facility: Halifax Medical Center
state: Florida
city: Fort Myers
country: United States
facility: Radiation Therapy Associates - Fort Myers
state: Florida
city: Gainesville
country: United States
facility: University of Florida Health Science Center
state: Florida
city: Melbourne
country: United States
facility: Health First Holmes Regional Medical Center
state: Florida
city: Miami Beach
country: United States
facility: CCOP - Mount Sinai Medical Center
state: Florida
city: Miami
country: United States
facility: Sylvester Cancer Center, University of Miami
state: Florida
city: Miami
country: United States
facility: Baptist Hospital of Miami
state: Florida
city: Orange Park
country: United States
facility: Florida Radiation Oncology Group
state: Florida
city: Orlando
country: United States
facility: MD Anderson Cancer Center Orlando
state: Florida
city: Panama City
country: United States
facility: Gulf Coast Cancer Treatment Center
state: Florida
city: Pensacola
country: United States
facility: West Florida Cancer Institute - Pensacola
state: Florida
city: Saint Petersburg
country: United States
facility: Bayfront Medical Center
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital - Atlanta
state: Georgia
city: Atlanta
country: United States
facility: CCOP - Atlanta Regional
state: Georgia
city: Rome
country: United States
facility: InterCommunity Cancer Center at Rome
state: Georgia
city: Valdosta
country: United States
facility: South Georgia Medical Center
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Cancer Research Center
state: Illinois
city: Harvey
country: United States
facility: Ingalls Memorial Hospital
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Park Ridge
country: United States
facility: Lutheran General Cancer Care Center
state: Illinois
city: Peoria
country: United States
facility: Methodist Medical Center of Illinois
state: Illinois
city: Springfield
country: United States
facility: CCOP - Central Illinois
state: Illinois
city: Urbana
country: United States
facility: CCOP - Carle Cancer Center
state: Illinois
city: Anderson
country: United States
facility: St. John's Medical Center
state: Indiana
city: Indianapolis
country: United States
facility: Clarion Health Partners Inc.
state: Indiana
city: Indianapolis
country: United States
facility: Community Hospitals of Indianapolis - Regional Cancer Center
state: Indiana
city: Muncie
country: United States
facility: Ball Memorial Hospital
state: Indiana
city: South Bend
country: United States
facility: Memorial Hospital of South Bend
state: Indiana
city: South Bend
country: United States
facility: St. Joseph's Radiation Oncology Center
state: Indiana
city: Dubuque
country: United States
facility: Wendt Regional Cancer Center of Finley Hospital
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Bowling Green
country: United States
facility: Medical Center at Bowling Green
state: Kentucky
city: Lexington
country: United States
facility: Veterans Affairs Medical Center - Lexington
state: Kentucky
city: Lexington
country: United States
facility: Albert B. Chandler Medical Center, University of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: James Graham Brown Cancer Center
state: Kentucky
city: Louisville
country: United States
facility: Louisville Radiation Oncology
state: Kentucky
city: Madisonville
country: United States
facility: Merle M. Mahr Cancer Center
state: Kentucky
city: Paducah
country: United States
facility: Western Baptist Hospital
state: Kentucky
city: Baton Rouge
country: United States
facility: Mary Bird Perkins Cancer Center
state: Louisiana
city: Lafayette
country: United States
facility: Romagosa Radiation Oncology Center
state: Louisiana
city: Metairie
country: United States
facility: East Jefferson General Hospital
state: Louisiana
city: New Orleans
country: United States
facility: MBCCOP - LSU Medical Center
state: Louisiana
city: New Orleans
country: United States
facility: CCOP - Ochsner
state: Louisiana
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Annapolis
country: United States
facility: Anne Arundel Oncology Center
state: Maryland
city: Baltimore
country: United States
facility: Marlene & Stewart Greenebaum Cancer Center, University of Maryland
state: Maryland
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center and Cancer Center
state: Maryland
city: Baltimore
country: United States
facility: Harbor Hospital Center
state: Maryland
city: Baltimore
country: United States
facility: Radiation Oncology Affiliates of Maryland, P.A.
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Oncology Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
city: Boston
country: United States
facility: Joint Center for Radiation Therapy
state: Massachusetts
city: Hyannis
country: United States
facility: Cape Cod Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: Veterans Affairs Medical Center - Ann Arbor
state: Michigan
city: Ann Arbor
country: United States
facility: CCOP - Ann Arbor Regional
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
city: Kalamazoo
country: United States
facility: CCOP - Kalamazoo
state: Michigan
city: Marquette
country: United States
facility: Marquette General Hospital
state: Michigan
city: Saginaw
country: United States
facility: St. Mary's Medical Center
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: Saint Louis Park
country: United States
facility: CCOP - Metro-Minnesota
state: Minnesota
city: Columbia
country: United States
facility: Ellis Fischel Cancer Center - Columbia
state: Missouri
city: Kansas City
country: United States
facility: CCOP - Kansas City
state: Missouri
city: Saint Louis
country: United States
facility: Veterans Affairs Medical Center - Saint Louis
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis University Health Sciences Center
state: Missouri
city: Saint Louis
country: United States
facility: Mallinckrodt Institute of Radiology
state: Missouri
city: Springfield
country: United States
facility: Cancer Research for the Ozarks
state: Missouri
city: Springfield
country: United States
facility: CCOP - Ozarks Regional
state: Missouri
city: Billings
country: United States
facility: CCOP - Montana Cancer Consortium
state: Montana
city: Omaha
country: United States
facility: Methodist Cancer Center - Omaha
state: Nebraska
city: Omaha
country: United States
facility: CCOP - Missouri Valley Cancer Consortium
state: Nebraska
city: Las Vegas
country: United States
facility: CCOP - Southern Nevada Cancer Research Foundation
state: Nevada
city: Lebanon
country: United States
facility: Norris Cotton Cancer Center
state: New Hampshire
city: Manchester
country: United States
facility: Elliot Regional Cancer Center
state: New Hampshire
city: East Orange
country: United States
facility: Veterans Affairs Medical Center - East Orange
state: New Jersey
city: Edison
country: United States
facility: John F. Kennedy Medical Center
state: New Jersey
city: Elizabeth
country: United States
facility: Elizabeth General Medical Center - West
state: New Jersey
city: Millville
country: United States
facility: South Jersey Hospital - Millville
state: New Jersey
city: Mount Holly
country: United States
facility: Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County
state: New Jersey
city: Toms River
country: United States
facility: Community Medical Center
state: New Jersey
city: Trenton
country: United States
facility: St. Francis Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: Saint Joseph Medical Center
state: New Mexico
city: Albany
country: United States
facility: Cancer Center of Albany Medical Center
state: New York
city: Albany
country: United States
facility: Veterans Affairs Medical Center - Albany
state: New York
city: Bronx
country: United States
facility: Albert Einstein Comprehensive Cancer Center
state: New York
city: Brooklyn
country: United States
facility: State University of New York Health Science Center at Brooklyn
state: New York
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
city: Manhasset
country: United States
facility: CCOP - North Shore University Hospital
state: New York
city: New York
country: United States
facility: Kaplan Cancer Center
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Plattsburgh
country: United States
facility: Champlain Valley Physicians Hospital Medical Center
state: New York
city: Poughkeepsie
country: United States
facility: Vassar Brothers Hospital
state: New York
city: Rochester
country: United States
facility: Genesee Hospital - Rochester
state: New York
city: Rochester
country: United States
facility: University of Rochester Cancer Center
state: New York
city: Valhalla
country: United States
facility: New York Medical College
state: New York
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center, UNC
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University School of Medicine
state: North Carolina
city: Winston-Salem
country: United States
facility: CCOP - Southeast Cancer Control Consortium
state: North Carolina
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
state: North Carolina
city: Fargo
country: United States
facility: Meritcare Roger Maris Cancer Center
state: North Dakota
city: Minot
country: United States
facility: UNI-MED Medical Center
state: North Dakota
city: Akron
country: United States
facility: Akron General Medical Center
state: Ohio
city: Akron
country: United States
facility: Akron City Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: Ireland Cancer Center
state: Ohio
city: Columbus
country: United States
facility: CCOP - Columbus
state: Ohio
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital - Ohio State University
state: Ohio
city: Dayton
country: United States
facility: Veterans Affairs Medical Center - Dayton
state: Ohio
city: Kettering
country: United States
facility: CCOP - Dayton
state: Ohio
city: Toledo
country: United States
facility: CCOP - Toledo Community Hospital Oncology Program
state: Ohio
city: Tulsa
country: United States
facility: St. John Medical Center
state: Oklahoma
city: Corvallis
country: United States
facility: Samaritan Regional Cancer Center
state: Oregon
city: Portland
country: United States
facility: CCOP - Columbia River Program
state: Oregon
city: Danville
country: United States
facility: Penn State Geisinger Medical Center
state: Pennsylvania
city: Darby
country: United States
facility: Mercy Catholic Medical Center, Mercy Fitzgerald Divison
state: Pennsylvania
city: Drexel Hill
country: United States
facility: Delaware County Memorial Hospital
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Geisinger Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Allegheny University Hospitals- Hahnemann
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Veterans Affairs Medical Center - Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Cancer Institute
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Western Pennsylvania Hospital
state: Pennsylvania
city: Reading
country: United States
facility: Reading Hospital and Medical Center
state: Pennsylvania
city: Scranton
country: United States
facility: Mercy Hospital Cancer Center - Scranton
state: Pennsylvania
city: Sellersville
country: United States
facility: Grand View Hospital
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Wilkes Barre General Hospital
state: Pennsylvania
city: Wynnewood
country: United States
facility: CCOP - MainLine Health
state: Pennsylvania
city: York
country: United States
facility: York Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Greenville
country: United States
facility: CCOP - Greenville
state: South Carolina
city: Spartanburg
country: United States
facility: CCOP - Upstate Carolina
state: South Carolina
city: Jackson
country: United States
facility: Jackson-Madison County General Hospital
state: Tennessee
city: Knoxville
country: United States
facility: Baptist Regional Cancer Center - Knoxville
state: Tennessee
city: Memphis
country: United States
facility: CCOP - Baptist Cancer Institute
state: Tennessee
city: Memphis
country: United States
facility: University of Tennessee, Memphis Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Cancer Center
state: Tennessee
city: Beaumont
country: United States
facility: Julie and Ben Rogers Cancer Institute
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: University of Texas - MD Anderson Cancer Center
state: Texas
city: Lackland Air Force Base
country: United States
facility: Wilford Hall - 59th Medical Wing
state: Texas
city: Pasadena
country: United States
facility: Bayshore Medical Center
state: Texas
city: Saint George
country: United States
facility: Dixie Regional Medical Center
state: Utah
city: Salt Lake City
country: United States
facility: LDS Hospital
state: Utah
city: Bennington
country: United States
facility: CCOP - Southwestern Vermont Regional Cancer Center
state: Vermont
city: Rutland
country: United States
facility: Green Mountain Oncology Group
state: Vermont
city: White River Junction
country: United States
facility: Veterans Affairs Medical Center - White River Junction
state: Vermont
city: Charlottesville
country: United States
facility: Martha Jefferson Hospital
state: Virginia
city: Charlottesville
country: United States
facility: Cancer Center, University of Virginia HSC
state: Virginia
city: Lynchburg
country: United States
facility: Virginia Baptist Hospital
state: Virginia
city: Portsmouth
country: United States
facility: Naval Medical Center, Portsmouth
state: Virginia
city: Richmond
country: United States
facility: Massey Cancer Center
state: Virginia
city: Seattle
country: United States
facility: Swedish Hospital Tumor Institute
state: Washington
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Spokane
country: United States
facility: Deaconess Medical Center
state: Washington
city: Yakima
country: United States
facility: Yakima Valley Memorial Hospital
state: Washington
city: Wheeling
country: United States
facility: Schiffler Oncology Center
state: West Virginia
city: Green Bay
country: United States
facility: St. Vincent Hospital
state: Wisconsin
city: La Crosse
country: United States
facility: Gundersen Lutheran Medical Foundation
state: Wisconsin
city: Madison
country: United States
facility: Veterans Affairs Medical Center - Madison
state: Wisconsin
city: Madison
country: United States
facility: Southern Wisconsin Radiotherapy Center
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin Comprehensive Cancer Center
state: Wisconsin
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
city: Menomonee Falls
country: United States
facility: Community Memorial Hospital
state: Wisconsin
city: Milwaukee
country: United States
facility: St. Joseph's Hospital
state: Wisconsin
city: Milwaukee
country: United States
facility: Columbia Hospital
state: Wisconsin
city: Milwaukee
country: United States
facility: St. Luke's Medical Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Veterans Affairs Medical Center - Milwaukee (Zablocki)
state: Wisconsin
city: Racine
country: United States
facility: Southeastern Wisconsin Regional Cancer Center
state: Wisconsin
city: Calgary
country: Canada
facility: Tom Baker Cancer Center - Calgary
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Victoria
country: Canada
facility: British Columbia Cancer Agency - Vancouver Island Cancer Centre
state: British Columbia
city: Moncton
country: Canada
facility: Doctor Leon Richard Oncology Centre
state: New Brunswick
city: Saint John
country: Canada
facility: Saint John Regional Hospital
state: New Brunswick
city: Halifax
country: Canada
facility: Nova Scotia Cancer Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: Cancer Care Ontario-Hamilton Regional Cancer Centre
state: Ontario
city: Kingston
country: Canada
facility: Kingston Regional Cancer Centre
state: Ontario
city: London
country: Canada
facility: Cancer Care Ontario-London Regional Cancer Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Regional Cancer Centre - Civic Campus
state: Ontario
city: Sudbury
country: Canada
facility: Northeastern Ontario Regional Cancer Centre, Sudbury
state: Ontario
city: Thunder Bay
country: Canada
facility: Northwestern Ontario Regional Cancer Centre, Thunder Bay
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: McGill University Department of Oncology
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal
state: Quebec
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre
state: Saskatchewan
Study officials:
affiliation: Barbara Ann Karmanos Cancer Institute
name: Francis G. LeVeque, DDS
role: STUDY_CHAIR
References:
citation: Scarantino C, LeVeque F, Swann RS, White R, Schulsinger A, Hodson DI, Meredith R, Foote R, Brachman D, Lee N. Effect of pilocarpine during radiation therapy: results of RTOG 97-09, a phase III randomized study in head and neck cancer patients. J Support Oncol. 2006 May;4(5):252-8.
citation: Fisher J, Scott C, Scarantino CW, Leveque FG, White RL, Rotman M, Hodson DI, Meredith RF, Foote R, Bachman DG, Lee N. Phase III quality-of-life study results: impact on patients' quality of life to reducing xerostomia after radiotherapy for head-and-neck cancer--RTOG 97-09. Int J Radiat Oncol Biol Phys. 2003 Jul 1;56(3):832-6. doi: 10.1016/s0360-3016(03)00121-4.
citation: Fisher JJ, Scott CB, Scarantino CW, et al.: Phase III quality of life (Qol) study: reduction in hyposalivation does not improve Qol for head and neck (H&N) cancer patients post radiation therapy (P-RT). RTOG 9709. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1423, 2002.
citation: Scarantino CW, Leveque FG, Scott CB, et al.: A phase III study of concomitant oral pilocarpine to reduce hypo-salivation and mucositis associated with curative radiation therapy (RT) in the head and neck (H&N) cancer patients. RTOG 9709. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-897, 225a, 2001.
citation: Scarantino CW, Leveque F, Scott C, et al.: A phase III study on the concurrent use of oral pilocarpine to reduce hyposalivation and mucositis associated with radiation therapy in head and neck cancer patients: final results of RTOG 97-09. [Abstract] Int J Radiat Oncol Biol Phys 51(3 suppl 1): A-157, 85-86, 2001.