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

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).

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