Pilocarpine and Prevention of Radiation Induced Xerostomia in HNSCC

Abstract

Stated Purpose: To evaluate the efficacy and safety of concomitant pilocarpine with radiation therapy for the prevention of radiation induced xerostomia in Head & Neck cancer. Material & methods: A prospective, randomized, study was carried out on sixty treatment naive histopathologically proven patients of squamous cell carcinoma of head and neck. All the patients received 64Gy/32Fraction/6.2wks with and without pilocarpine. The study group received concomitant Pilocarpine hydrochloride 5.0 mg four times a day, starting three days prior to start of radiotherapy, continued for 3-months. Patients were evaluated at four points for xerostomia using subjective and objective scale. The Zimmermans Xerostomia Questionnaire and Visual Analogue Scale were used for evaluation of results. The statistical analysis was done by Paired sample T test and Mann-Whiteny U-Test. Results: The average Zimmerman Xerostomia scores of the pilocarpine group as compared to the control group were: First assessment - 100mm Vs 100mm; Second assessment - 48mm Vs 37mm; Third assessment - 57mm Vs 41mm; Fourth assessment - 62 Vs 44mm. The average LENT SOMA grades for the study group and the control group along with SEM respectively were: First assessment 1 Vs 1; Second assessment 2.7 (SEM-8.510X10-2) Vs 3 (SEM -0.000); Third assessment 2.3 (SEM -0.1150) Vs 2.5 (SEM -9.285X10-2); Fourth assessment 2.3 (SEM - 0.1150) Vs 2.5 (SEM -9.285X102). The RTOG Salivary Gland Morbidity Scores for the study group and the control group respectively were: First assessment – 0 Vs 0; Second assessment - 1.8 Vs 2 (p Value-0.595); Third assessment - 1.6 Vs 1.8 (p Value -0.094); Fourth assessment - 1.6 Vs 1.8 (p Value-0.054). Conclusion: The objective assessment of xerostomia done by these scales were favorable in the study group as compared to the control group signifying that concomitant pilocarpine preserved better salivary gland function.