Phase III randomized study: Oral pilocarpine versus submandibular salivary gland transfer protocol for the management of radiation-induced xerostomia

✍ Scribed by Naresh Jha; Hadi Seikaly; Jeffrey Harris; David Williams; Khalil Sultanem; Michael Hier; Sunita Ghosh; Martin Black; James Butler; Donna Sutherland; Paul Kerr; Pam Barnaby

• Publisher: John Wiley and Sons
• Year: 2009
• Tongue: English
• Weight: 190 KB
• Volume: 31
• Category: Article
• ISSN: 1043-3074
• DOI: 10.1002/hed.20961

✦ Synopsis

Abstract

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 QOL) 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. © 2008 Wiley Periodicals, Inc. Head Neck, 2009