Pilocarpine in Preventing Mucositis and Dry Mouth in Patients Receiving Radiation Therapy for Head and Neck Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer; Oral Complications
• Intervention / Treatment: Other: Placebo; Drug: pilocarpine hydrochloride

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).

• Study Type: Interventional
• Enrollment (Actual): 249
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Tom Baker Cancer Center - Calgary
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • British Columbia
    • Victoria, British Columbia, Canada, V8R 1J8
      • British Columbia Cancer Agency - Vancouver Island Cancer Centre
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 8X3
      • Doctor Leon Richard Oncology Centre
    • Saint John, New Brunswick, Canada, E2L 4L2
      • Saint John Regional Hospital
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Nova Scotia Cancer Centre
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Cancer Care Ontario-Hamilton Regional Cancer Centre
    • Kingston, Ontario, Canada, K7L 5P9
      • Kingston Regional Cancer Centre
    • London, Ontario, Canada, N6A 4L6
      • Cancer Care Ontario-London Regional Cancer Centre
    • Ottawa, Ontario, Canada, K1Y 4K7
      • Ottawa Regional Cancer Centre - Civic Campus
    • Sudbury, Ontario, Canada, P3E 5J1
      • Northeastern Ontario Regional Cancer Centre, Sudbury
    • Thunder Bay, Ontario, Canada, P7A 7T1
      • Northwestern Ontario Regional Cancer Centre, Thunder Bay
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Hospital
  • Quebec
    • Montreal, Quebec, Canada, H2W 1S6
      • McGill University Department of Oncology
    • Montreal, Quebec, Canada, H2W-W1T8
      • Centre Hospitalier de l'Université de Montréal
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 4H4
      • Saskatoon Cancer Centre
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Veterans Affairs Medical Center - Birmingham
    • Birmingham, Alabama, United States, 35294
      • University of Alabama Comprehensive Cancer Center
    • Huntsville, Alabama, United States, 35801
      • Huntsville Hospital System
    • Mobile, Alabama, United States, 36688
      • MBCCOP - University of South Alabama
    • Mobile, Alabama, United States, 36640
      • Urology Associates - Mobile AL
    • Montgomery, Alabama, United States, 36106-2801
      • Alabama Oncology, LLC
    • Tuscallosa, Alabama, United States, 35401
      • Radiation Oncology Associates of West Alabama
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Providence Cancer Therapy Center
  • Arizona
    • Tucson, Arizona, United States, 85724
      • Arizona Cancer Center
  • California
    • Burbank, California, United States, 91505
      • Providence Saint Joseph Medical Center - Burbank
    • Concord, California, United States, 94524-4110
      • Mount Diablo Medical Center
    • Duarte, California, United States, 91010
      • Beckman Research Institute, City of Hope
    • Fresno, California, United States, 93720
      • California Cancer Center
    • Fresno, California, United States, 93720
      • Saint Agnes Cancer Center
    • Glendale, California, United States, 91204
      • Glendale Memorial Hospital and Health Center
    • Greenbrae, California, United States, 94904
      • Sutter Health Western Division Cancer Research Group
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center
    • Long Beach, California, United States, 90822
      • Veterans Affairs Medical Center - Long Beach
    • Los Angeles, California, United States, 90033-0800
      • USC/Norris Comprehensive Cancer Center
    • Los Angeles, California, United States, 90095-1781
      • Jonsson Comprehensive Cancer Center, UCLA
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente Medical Center - Los Angeles
    • Martinez, California, United States, 94553
      • Veterans Affairs Outpatient Clinic - Martinez
    • Oakland, California, United States, 94609-3305
      • CCOP - Bay Area Tumor Institute
    • Pomona, California, United States, 91767
      • Cancer Care Center
    • Redding, California, United States, 96099-6009
      • Mercy Medical Center - Redding
    • Sacramento, California, United States, 95816
      • Radiation Oncology Center - Sacramento
    • San Francisco, California, United States, 94115-0128
      • UCSF Cancer Center and Cancer Research Institute
    • Santa Cruz, California, United States, 95065
      • Santa Cruz Radiation Oncology Medical Group, Inc.
    • Santa Rosa, California, United States, 95403
      • CCOP - Santa Rosa Memorial Hospital
    • Stanford, California, United States, 94305
      • Stanford University
    • Travis Air Force Base, California, United States, 94535
      • David Grant Medical Center
    • Walnut Creek, California, United States, 94598
      • Radiation Oncology Center - Walnut Creek
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Memorial Hospital Cancer Center
    • Denver, Colorado, United States, 80262
      • University of Colorado Cancer Center
  • Connecticut
    • Bridgeport, Connecticut, United States, 06610
      • Bridgeport Hospital
    • Norwalk, Connecticut, United States, 06856
      • Whittingham Cancer Center
  • Delaware
    • Wilmington, Delaware, United States, 19899
      • CCOP - Christiana Care Health Services
  • District of Columbia
    • Washington, District of Columbia, United States, 20307-5000
      • Walter Reed Army Medical Center
  • Florida
    • Clearwater, Florida, United States, 33757-0210
      • Lykes Center for Radiation Therapy
    • Daytona Beach, Florida, United States, 32114
      • Halifax Medical Center
    • Fort Myers, Florida, United States, 33901
      • Radiation Therapy Associates - Fort Myers
    • Gainesville, Florida, United States, 32610-0296
      • University of Florida Health Science Center
    • Melbourne, Florida, United States, 32901
      • Health First Holmes Regional Medical Center
    • Miami, Florida, United States, 33136
      • Sylvester Cancer Center, University of Miami
    • Miami, Florida, United States, 33176-2197
      • Baptist Hospital of Miami
    • Miami Beach, Florida, United States, 33140
      • CCOP - Mount Sinai Medical Center
    • Orange Park, Florida, United States, 32073
      • Florida Radiation Oncology Group
    • Orlando, Florida, United States, 32806
      • MD Anderson Cancer Center Orlando
    • Panama City, Florida, United States, 32405-4587
      • Gulf Coast Cancer Treatment Center
    • Pensacola, Florida, United States, 32514
      • West Florida Cancer Institute - Pensacola
    • Saint Petersburg, Florida, United States, 33701
      • Bayfront Medical Center
    • Tampa, Florida, United States, 33612
      • H. Lee Moffitt Cancer Center and Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital - Atlanta
    • Atlanta, Georgia, United States, 30342-1701
      • CCOP - Atlanta Regional
    • Rome, Georgia, United States, 30161
      • InterCommunity Cancer Center at Rome
    • Valdosta, Georgia, United States, 31603
      • South Georgia Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
    • Chicago, Illinois, United States, 60637
      • University of Chicago Cancer Research Center
    • Harvey, Illinois, United States, 60426
      • Ingalls Memorial Hospital
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
    • Park Ridge, Illinois, United States, 60068
      • Lutheran General Cancer Care Center
    • Peoria, Illinois, United States, 61636
      • Methodist Medical Center of Illinois
    • Springfield, Illinois, United States, 62526
      • CCOP - Central Illinois
    • Urbana, Illinois, United States, 61801
      • CCOP - Carle Cancer Center
  • Indiana
    • Anderson, Indiana, United States, 46016
      • St. John's Medical Center
    • Indianapolis, Indiana, United States, 46206-1367
      • Clarion Health Partners Inc.
    • Indianapolis, Indiana, United States, 46219
      • Community Hospitals of Indianapolis - Regional Cancer Center
    • Muncie, Indiana, United States, 47303-3499
      • Ball Memorial Hospital
    • South Bend, Indiana, United States, 46601
      • Memorial Hospital of South Bend
    • South Bend, Indiana, United States, 46617
      • St. Joseph's Radiation Oncology Center
  • Iowa
    • Dubuque, Iowa, United States, 52001
      • Wendt Regional Cancer Center of Finley Hospital
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Kentucky
    • Bowling Green, Kentucky, United States, 42102
      • Medical Center at Bowling Green
    • Lexington, Kentucky, United States, 40511-1093
      • Veterans Affairs Medical Center - Lexington
    • Lexington, Kentucky, United States, 40536-0084
      • Albert B. Chandler Medical Center, University of Kentucky
    • Louisville, Kentucky, United States, 40202
      • James Graham Brown Cancer Center
    • Louisville, Kentucky, United States, 40215
      • Louisville Radiation Oncology
    • Madisonville, Kentucky, United States, 42431
      • Merle M. Mahr Cancer Center
    • Paducah, Kentucky, United States, 42001
      • Western Baptist Hospital
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Mary Bird Perkins Cancer Center
    • Lafayette, Louisiana, United States, 70501
      • Romagosa Radiation Oncology Center
    • Metairie, Louisiana, United States, 70011
      • East Jefferson General Hospital
    • New Orleans, Louisiana, United States, 70112
      • MBCCOP - LSU Medical Center
    • New Orleans, Louisiana, United States, 70121
      • CCOP - Ochsner
  • Maine
    • Portland, Maine, United States, 04102
      • Maine Medical Center
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Anne Arundel Oncology Center
    • Baltimore, Maryland, United States, 21201
      • Marlene & Stewart Greenebaum Cancer Center, University of Maryland
    • Baltimore, Maryland, United States, 21204
      • Greater Baltimore Medical Center and Cancer Center
    • Baltimore, Maryland, United States, 21225
      • Harbor Hospital Center
    • Baltimore, Maryland, United States, 21237
      • Radiation Oncology Affiliates of Maryland, P.A.
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Oncology Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital Cancer Center
    • Boston, Massachusetts, United States, 02215
      • Joint Center for Radiation Therapy
    • Hyannis, Massachusetts, United States, 02601
      • Cape Cod Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-0752
      • University of Michigan Comprehensive Cancer Center
    • Ann Arbor, Michigan, United States, 48105
      • Veterans Affairs Medical Center - Ann Arbor
    • Ann Arbor, Michigan, United States, 48106
      • CCOP - Ann Arbor Regional
    • Detroit, Michigan, United States, 48201
      • Barbara Ann Karmanos Cancer Institute
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Flint, Michigan, United States, 48503
      • Hurley Medical Center
    • Kalamazoo, Michigan, United States, 49007-3731
      • CCOP - Kalamazoo
    • Marquette, Michigan, United States, 49855
      • Marquette General Hospital
    • Saginaw, Michigan, United States, 48601
      • St. Mary's Medical Center
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Cancer Center
    • Saint Louis Park, Minnesota, United States, 55416
      • CCOP - Metro-Minnesota
  • Missouri
    • Columbia, Missouri, United States, 65203
      • Ellis Fischel Cancer Center - Columbia
    • Kansas City, Missouri, United States, 64131
      • CCOP - Kansas City
    • Saint Louis, Missouri, United States, 63110-0250
      • St. Louis University Health Sciences Center
    • Saint Louis, Missouri, United States, 63106
      • Veterans Affairs Medical Center - Saint Louis
    • Saint Louis, Missouri, United States, 63110
      • Mallinckrodt Institute of Radiology
    • Springfield, Missouri, United States, 65807
      • Cancer Research for the Ozarks
    • Springfield, Missouri, United States, 65807
      • CCOP - Ozarks Regional
  • Montana
    • Billings, Montana, United States, 59101
      • CCOP - Montana Cancer Consortium
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Methodist Cancer Center - Omaha
    • Omaha, Nebraska, United States, 68131
      • CCOP - Missouri Valley Cancer Consortium
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • CCOP - Southern Nevada Cancer Research Foundation
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Norris Cotton Cancer Center
    • Manchester, New Hampshire, United States, 03103
      • Elliot Regional Cancer Center
  • New Jersey
    • East Orange, New Jersey, United States, 07018-1095
      • Veterans Affairs Medical Center - East Orange
    • Edison, New Jersey, United States, 08818
      • John F. Kennedy Medical Center
    • Elizabeth, New Jersey, United States, 07201
      • Elizabeth General Medical Center - West
    • Millville, New Jersey, United States, 08332
      • South Jersey Hospital - Millville
    • Mount Holly, New Jersey, United States, 08060
      • Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County
    • Toms River, New Jersey, United States, 08755
      • Community Medical Center
    • Trenton, New Jersey, United States, 08629
      • St. Francis Medical Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Saint Joseph Medical Center
  • New York
    • Albany, New York, United States, 12208
      • Cancer Center of Albany Medical Center
    • Albany, New York, United States, 12208
      • Veterans Affairs Medical Center - Albany
    • Bronx, New York, United States, 10461
      • Albert Einstein Comprehensive Cancer Center
    • Brooklyn, New York, United States, 11203
      • State University of New York Health Science Center at Brooklyn
    • Brooklyn, New York, United States, 11215-3609
      • New York Methodist Hospital
    • Manhasset, New York, United States, 11030
      • CCOP - North Shore University Hospital
    • New York, New York, United States, 10021
      • Memorial Sloan-Kettering Cancer Center
    • New York, New York, United States, 10016
      • Kaplan Cancer Center
    • Plattsburgh, New York, United States, 12901
      • Champlain Valley Physicians Hospital Medical Center
    • Poughkeepsie, New York, United States, 12601
      • Vassar Brothers Hospital
    • Rochester, New York, United States, 14607
      • Genesee Hospital - Rochester
    • Rochester, New York, United States, 14642
      • University of Rochester Cancer Center
    • Valhalla, New York, United States, 10595
      • New York Medical College
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7295
      • Lineberger Comprehensive Cancer Center, UNC
    • Greenville, North Carolina, United States, 27858-4354
      • East Carolina University School of Medicine
    • Winston-Salem, North Carolina, United States, 27104-4241
      • CCOP - Southeast Cancer Control Consortium
    • Winston-Salem, North Carolina, United States, 27157-1082
      • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
  • North Dakota
    • Fargo, North Dakota, United States, 58122
      • Meritcare Roger Maris Cancer Center
    • Minot, North Dakota, United States, 58701
      • UNI-MED Medical Center
  • Ohio
    • Akron, Ohio, United States, 44302
      • Akron General Medical Center
    • Akron, Ohio, United States, 44309
      • Akron City Hospital
    • Cincinnati, Ohio, United States, 45219
      • Christ Hospital
    • Cleveland, Ohio, United States, 44106-5065
      • Ireland Cancer Center
    • Columbus, Ohio, United States, 43206
      • CCOP - Columbus
    • Columbus, Ohio, United States, 43210
      • Arthur G. James Cancer Hospital - Ohio State University
    • Dayton, Ohio, United States, 45428
      • Veterans Affairs Medical Center - Dayton
    • Kettering, Ohio, United States, 45429
      • CCOP - Dayton
    • Toledo, Ohio, United States, 43623-3456
      • CCOP - Toledo Community Hospital Oncology Program
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • St. John Medical Center
  • Oregon
    • Corvallis, Oregon, United States, 97339
      • Samaritan Regional Cancer Center
    • Portland, Oregon, United States, 97213
      • CCOP - Columbia River Program
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822-2001
      • Penn State Geisinger Medical Center
    • Darby, Pennsylvania, United States, 19023
      • Mercy Catholic Medical Center, Mercy Fitzgerald Divison
    • Drexel Hill, Pennsylvania, United States, 19026
      • Delaware County Memorial Hospital
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Geisinger Cancer Center
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
    • Philadelphia, Pennsylvania, United States, 19102-1192
      • Allegheny University Hospitals- Hahnemann
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Cancer Center
    • Philadelphia, Pennsylvania, United States, 19104
      • Veterans Affairs Medical Center - Philadelphia
    • Philadelphia, Pennsylvania, United States, 19107
      • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
    • Philadelphia, Pennsylvania, United States, 19141
      • Albert Einstein Cancer Center
    • Pittsburgh, Pennsylvania, United States, 15224
      • Western Pennsylvania Hospital
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Cancer Institute
    • Reading, Pennsylvania, United States, 19612-6052
      • Reading Hospital and Medical Center
    • Scranton, Pennsylvania, United States, 18501
      • Mercy Hospital Cancer Center - Scranton
    • Sellersville, Pennsylvania, United States, 18960
      • Grand View Hospital
    • Wilkes-Barre, Pennsylvania, United States, 18764
      • Wilkes Barre General Hospital
    • Wynnewood, Pennsylvania, United States, 19096
      • CCOP - MainLine Health
    • York, Pennsylvania, United States, 17315
      • York Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425-0721
      • Medical University of South Carolina
    • Greenville, South Carolina, United States, 29615
      • CCOP - Greenville
    • Spartanburg, South Carolina, United States, 29303
      • CCOP - Upstate Carolina
  • Tennessee
    • Jackson, Tennessee, United States, 38301
      • Jackson-Madison County General Hospital
    • Knoxville, Tennessee, United States, 37901
      • Baptist Regional Cancer Center - Knoxville
    • Memphis, Tennessee, United States, 38117
      • CCOP - Baptist Cancer Institute
    • Memphis, Tennessee, United States, 38163
      • University of Tennessee, Memphis Cancer Center
    • Nashville, Tennessee, United States, 37232-6838
      • Vanderbilt Cancer Center
  • Texas
    • Beaumont, Texas, United States, 77701
      • Julie and Ben Rogers Cancer Institute
    • Galveston, Texas, United States, 77555-1329
      • University of Texas Medical Branch
    • Houston, Texas, United States, 77030
      • University of Texas - MD Anderson Cancer Center
    • Lackland Air Force Base, Texas, United States, 78236-5300
      • Wilford Hall - 59th Medical Wing
    • Pasadena, Texas, United States, 77504
      • Bayshore Medical Center
  • Utah
    • Saint George, Utah, United States, 84770
      • Dixie Regional Medical Center
    • Salt Lake City, Utah, United States, 84143
      • LDS Hospital
  • Vermont
    • Bennington, Vermont, United States, 05201
      • CCOP - Southwestern Vermont Regional Cancer Center
    • Rutland, Vermont, United States, 05701
      • Green Mountain Oncology Group
    • White River Junction, Vermont, United States, 05009
      • Veterans Affairs Medical Center - White River Junction
  • Virginia
    • Charlottesville, Virginia, United States, 22901
      • Martha Jefferson Hospital
    • Charlottesville, Virginia, United States, 22908
      • Cancer Center, University of Virginia HSC
    • Lynchburg, Virginia, United States, 24503
      • Virginia Baptist Hospital
    • Portsmouth, Virginia, United States, 23708-2197
      • Naval Medical Center, Portsmouth
    • Richmond, Virginia, United States, 23298-0037
      • Massey Cancer Center
  • Washington
    • Seattle, Washington, United States, 98104
      • Swedish Hospital Tumor Institute
    • Seattle, Washington, United States, 98111
      • Virginia Mason Medical Center
    • Spokane, Washington, United States, 99210-0248
      • Deaconess Medical Center
    • Yakima, Washington, United States, 98902
      • Yakima Valley Memorial Hospital
  • West Virginia
    • Wheeling, West Virginia, United States, 26003
      • Schiffler Oncology Center
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54307-3508
      • St. Vincent Hospital
    • La Crosse, Wisconsin, United States, 54601
      • Gundersen Lutheran Medical Foundation
    • Madison, Wisconsin, United States, 53705
      • Veterans Affairs Medical Center - Madison
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Comprehensive Cancer Center
    • Madison, Wisconsin, United States, 53713
      • Southern Wisconsin Radiotherapy Center
    • Marshfield, Wisconsin, United States, 54449
      • Marshfield Clinic
    • Menomonee Falls, Wisconsin, United States, 53051
      • Community Memorial Hospital
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin
    • Milwaukee, Wisconsin, United States, 53210
      • St. Joseph's Hospital
    • Milwaukee, Wisconsin, United States, 53211
      • Columbia Hospital
    • Milwaukee, Wisconsin, United States, 53215
      • St. Luke's Medical Center
    • Milwaukee, Wisconsin, United States, 53295
      • Veterans Affairs Medical Center - Milwaukee (Zablocki)
    • Racine, Wisconsin, United States, 53405
      • Southeastern Wisconsin Regional Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pilocarpine hydrocloride; 5mg pilocarpine hydrochloride tablets commencing 3 days prior to irradiation	Drug: pilocarpine hydrochloride; 5mg pilocarpine hydrochloride tablets
Placebo Comparator: Placebo; Placebo tablets commencing 3 days prior to irradiation	Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Acute salivary gland toxicity	From the start of treatment to 13 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Radiation Therapy Oncology Group
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Francis G. LeVeque, DDS, Barbara Ann Karmanos Cancer Institute

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 1998
• Primary Completion (Actual): January 1, 2001
• Study Completion (Actual): October 1, 2002

Study Registration Dates

• First Submitted: November 1, 1999
• First Submitted That Met QC Criteria: September 3, 2004
• First Posted (Estimate): September 6, 2004

Study Record Updates

• Last Update Posted (Estimate): November 17, 2015
• Last Update Submitted That Met QC Criteria: November 14, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: oral complications; lip and oral cavity squamous cell carcinoma; oropharyngeal squamous cell carcinoma
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Head and Neck Neoplasms; Mucositis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Cholinergic Agonists; Miotics; Muscarinic Agonists; Pilocarpine
• Other Study ID Numbers: RTOG-9709; CDR0000065912; NCI-P97-0121

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No