Efficacy of Oral Pilocarpine for Reduction of Post Radiotherapy Xerostomia in Head and Neck Cancer Patients: A Prospective Randomized Institution-based Study

Abstract

Purpose of study: To evaluate the efficacy and safety of oral pilocarpine concomitantly with radiation treatment for the prevention of radiation induced xerostomia in Head and Neck cancer patients. Material and methods: A prospective randomized study was carried out on 60 histopathological proven squamous cell cancer patients of Head and neck region. All patients received a total radiation dose of 66Gy /33 fraction/6.2 weeks (2Gy/fraction, 5 days/ week) on Telecobalt machine with or without concurrent chemotherapy. The concurrent chemotherapy eligible patients received, weekly chemotherapy courses using cisplatin 30 mg/m2. Patients in the study group received oral pilocarpine 5.0 mg three times a day starting 3 days prior to start of radiotherapy and continued for 3 months post radiotherapy. Patients were evaluated on subjective basis based on Zimmerman Questionnaire and EORTC QLQ HN 35. The statistical analysis was done by Paired sample T test. Results: The average Zimmerman Xerostomia score for all parameters combined was as follows: First assessment -100mm vs 100mm; Second assessment -50mm vs 45mm; Third assessment -59mm vs 52mm; Fourth assessment -64mm vs 57mm, Fifth assessment -71mm vs 68. As per QLQ-HN 35 questionnaire used for assessment of quality of life of patients in both groups, we observed that better scores were obtained in the pilocarpine group in comparison to control group. Conclusion: In the present study, the effectiveness of Pilocarpine given during and 3 months post radiotherapy was observed in terms of better compliance during radiation treatment. Most of the patients had less subjective symptoms with lesser grades of toxicities observed during various phases of assessment post RT.