Phase III randomized study: Oral pilocarpine versus submandibular salivary gland transfer protocol for the management of radiation-induced xerostomia
Article first published online: 23 DEC 2008
Copyright © 2008 Wiley Periodicals, Inc.
Head & Neck
Volume 31, Issue 2, pages 234–243, February 2009
How to Cite
Jha, N., Seikaly, H., Harris, J., Williams, D., Sultanem, K., Hier, M., Ghosh, S., Black, M., Butler, J., Sutherland, D., Kerr, P. and Barnaby, P. (2009), Phase III randomized study: Oral pilocarpine versus submandibular salivary gland transfer protocol for the management of radiation-induced xerostomia. Head Neck, 31: 234–243. doi: 10.1002/hed.20961
- Issue published online: 12 JAN 2009
- Article first published online: 23 DEC 2008
- Manuscript Accepted: 17 JUL 2008
- Alberta Cancer Board
- salivary gland transfer procedure;
Xerostomia is a serious morbidity of radiation treatment in head and neck cancer.
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.
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.
Submandibular SGT procedure is superior to pilocarpine in management of radiation-induced xerostomia. © 2008 Wiley Periodicals, Inc. Head Neck, 2009