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

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.

• Authors: Naresh Jha, Hadi Seikaly, Jeffrey Harris, David Williams, Khalil Sultanem, Michael Hier, Sunita Ghosh, Martin Black, James Butler, Donna Sutherland, Paul Kerr, Pam Barnaby
• Journal: Head & neck (Head Neck) Vol. 31 Issue 2 Pg. 234-43 (Feb 2009) ISSN: 1097-0347 [Electronic] United States
• PMID: 19107948 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Muscarinic Agonists
• Pilocarpine

Topics

• Administration, Oral
• Aged
• Carcinoma, Squamous Cell (radiotherapy)
• Disease-Free Survival
• Female
• Head and Neck Neoplasms (radiotherapy)
• Humans
• Male
• Middle Aged
• Muscarinic Agonists (administration & dosage, therapeutic use)
• Pilocarpine (administration & dosage, therapeutic use)
• Prospective Studies
• Radiotherapy (adverse effects)
• Submandibular Gland (transplantation)
• Treatment Outcome
• Xerostomia (drug therapy, etiology, surgery)