Randomized double blind, placebo-controlled study of pilocarpine administered during head and neck irradiation to reduce xerostomia.

ABSTRACT

PURPOSE: Pilocarpine hydrochloride administered during head and neck irradiation was evaluated for its ability to relieve xerostomia and its adverse effects. MATERIAL AND METHOD: A total of 60 head and neck cancer patients were enrolled in a randomized, double blind, placebo-controlled trial. Each patient had both parotid glands treated with a radiation dose of at least 50 Gy. Patients received jelly containing pilocarpine or placebo 5.0 mg (1 cc.) tid at meal times during radiation. Pilocarpine was administered beginning on the first day of radiation and continued until radiation was completed. Patients were evaluated for symptomatic relief by responding to questionnaires using a Visual Analogue Scale (VAS). Questionnaires measured relief of oral dryness, oral discomfort, difficulty in chewing and swallowing, speaking, and sleeping. Evaluation was conducted preradiation as a baseline, weekly during radiation and monthly until 6 months after radiation was completed. RESULTS: The baseline characteristics, disease and radiation technique including field arrangement and total dose, were not significantly different between the two groups. There was no statistically significant subjective difference in xerostomia, including oral dryness, oral discomfort, inability to chew and swallow, speak and sleep, during and postradiation between the two groups. The adverse effects were non-specific symptoms such as nausea, vomitting, dizziness, urinary frequency, palpitation, sweating and tearing. The adverse effects during radiation and postradiation were not significantly different between the two groups. CONCLUSION: It was concluded that pilocarpine hydrochloride administered during head and neck irradiation produced subjectively insignificant benefit in relieving xerostomia with acceptable side effects.