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Head Neck. 2009 Feb;31(2):234-43. doi: 10.1002/hed.20961.

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

Author information

1
Department of Radiation Oncology, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada. nareshj@cancerboard.ab.ca

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.

PMID:
19107948
DOI:
10.1002/hed.20961
[Indexed for MEDLINE]
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