Double-blind randomized, placebo-controlled study of pilocarpine to salvage salivary gland function during radiotherapy of patients with head and neck cancer

Abstract

Objective: The efficacy of pilocarpine given during radiotherapy for head-neck cancer to reduce xerostomia was assessed.

Study design: 58 patients receiving 5000 cGy radiotherapy (RT) involving salivary glands bilaterally were selected at the Jewish General Hospital, Montreal, Canada. Patients were randomly assigned to pilocarpine (5 mg, PILO, n=29) or placebo group (PLA, n=29). These drugs were taken 5 times daily during radiotherapy (first study phase) and 4 times daily for 5 weeks thereafter (second study phase). Saliva was collected and estimated for not stimulated and stimulated patients using the SAXON method.

Results: At the conclusion of the first phase, PILO patients reported a better global quality of life (P=.02) and less oral discomfort (P=.001) when compared to PLA. No significant difference was noted in the level of saliva, xerostomia, and other symptoms between patients in PILO and PLA. At the end of the second phase, a difference between groups was observed only for xerostomia and mucosal pain; both were significantly higher in PILO when compared to PLA (P <.05).

Conclusion: Pilocarpine 5mg given 5 times daily did not appear to improve the production of saliva and global quality of life assessments, nor to decrease the symptoms of xerostomia 5 weeks after completion of RT in patients who were taking pilocarpine post-RT. There was a slight improvement in the quality of life and a decrease in the level of discomfort noted only after the first study phase. The limitations of this study are discussed.