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 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.
Jha
Naresh
N
Department of Radiation Oncology, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada. nareshj@cancerboard.ab.ca
Seikaly
Hadi
H
Harris
Jeffrey
J
Williams
David
D
Sultanem
Khalil
K
Hier
Michael
M
Ghosh
Sunita
S
Black
Martin
M
Butler
James
J
Sutherland
Donna
D
Kerr
Paul
P
Barnaby
Pam
P
D000284:Administration, Oral; D000368:Aged; D002294:Carcinoma, Squamous Cell / Q000532:radiotherapy; D018572:Disease-Free Survival; D005260:Female; D006258:Head and Neck Neoplasms / Q000532:radiotherapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D018721:Muscarinic Agonists / Q000008:administration & dosage / Q000627:therapeutic use*; D010862:Pilocarpine / Q000008:administration & dosage / Q000627:therapeutic use*; D011446:Prospective Studies; D011878:Radiotherapy / Q000009:adverse effects; D013363:Submandibular Gland / Q000637:transplantation*; D016896:Treatment Outcome; D014987:Xerostomia / Q000188:drug therapy* / Q000209:etiology / Q000601:surgery*
D018721:Muscarinic Agonists; D010862:Pilocarpine