Pilocarpine in Preventing Mucositis and Dry Mouth in Patients Receiving Radiation Therapy for Head and Neck Cancer
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.
Head and Neck Cancer
Drug: pilocarpine hydrochloride
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
|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|
- Acute salivary gland toxicity [ Time Frame: From the start of treatment to 13 weeks ] [ Designated as safety issue: Yes ]
- Acute mucositis in the pharynx, palate, tongue, or buccal [ Time Frame: From the start of treatment to 13 weeks ] [ Designated as safety issue: Yes ]
- Quality of life as measured by the University of Washington Head and Neck Symptom questionnaire [ Time Frame: Pretreatment to 26 weeks from the start of treatment ] [ Designated as safety issue: No ]
- Effects of continuing pilocarpine out to 6 months from the start of treatment [ Time Frame: From the start of treatment to 26 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 1998|
|Study Completion Date:||October 2002|
|Primary Completion Date:||January 2001 (Final data collection date for primary outcome measure)|
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
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).