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)
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
Scroll for more (222 remaining)Veterans Affairs Medical Center - Birmingham🇺🇸Birmingham, Alabama, United States