PHASE III RANDOMIZED STUDY: ORAL PILOCARPINE VERSUS SUBMANDIBULAR SALIVARY GLAND TRANSFER PROTOCOL FOR THE MANAGEMENT OF RADIATION-INDUCED XEROSTOMIA

Background. Xerostomia is a serious morbidity of radiation treatment in head and neck cancer. Methods. We conducted a prospective phase III multicenter randomized study comparing submandibular salivary gland transfer (SGT) procedure with pilocarpine during and for 3 months after XRT. Salivary flow (baseline, stimulated) and University of Washington Quality of Life Questionnaire (U of W QOL) scores were measured. Results. An interim intent to treat analysis (120 patients) at 6 months shows superior results in SGT arm: median baseline salivary flow for SGT (0.04 mL/minute) versus pilocarpine (0.01 mL/minute), p = .001, median stimulated salivary flow (0.18 mL/minute) for SGT versus (0.05 mL/minute) for pilocarpine, p = .003. Scores (U of W COL) for amount (p = .017) and consistency of saliva (p = .005) in favor of SGT leading to premature closure of study. Conclusions. Submandibular SGT procedure is superior to pilocarpine in management of radiation-induced xerostomia. (C) 2008 Wiley Periodicals, Inc. Head Neck 31: 234-243, 2009