title: 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.affiliation: Department of Radiation Oncology, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada. nareshj@cancerboard.ab.ca
authors.forename: Naresh
authors.initials: N
authors.lastname: Jha
authors.forename: Hadi
authors.initials: H
authors.lastname: Seikaly
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Harris
authors.forename: David
authors.initials: D
authors.lastname: Williams
authors.forename: Khalil
authors.initials: K
authors.lastname: Sultanem
authors.forename: Michael
authors.initials: M
authors.lastname: Hier
authors.forename: Sunita
authors.initials: S
authors.lastname: Ghosh
authors.forename: Martin
authors.initials: M
authors.lastname: Black
authors.forename: James
authors.initials: J
authors.lastname: Butler
authors.forename: Donna
authors.initials: D
authors.lastname: Sutherland
authors.forename: Paul
authors.initials: P
authors.lastname: Kerr
authors.forename: Pam
authors.initials: P
authors.lastname: Barnaby
mesh_terms: 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*
chemical_list: D018721:Muscarinic Agonists; D010862:Pilocarpine