title: Xerostomia health-related quality of life: NRG oncology RTOG 0537.
abstract: The purpose of this secondary analysis was to determine change in overall health-related quality of life (HRQOL) based on patient data obtained from NRG Oncology RTOG 0537 as measured by the RTOG-modified University of Washington Head and Neck Symptom Score (RM-UWHNSS).
  
  
  
  A multi-site prospective randomized clinical trial design stratified 137 patients with post-radiation therapy xerostomia according to prior pilocarpine (PC) treatment and time after radiation therapy and/or chemotherapy and randomized patients into two groups. Patients were assigned to acupuncture or PC. Twenty-four sessions of acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) were administered over 12 weeks, or oral PC (5 mg) three times daily over the same 12 weeks. The RM-UWHNSS was administered at baseline and at 4, 6, 9, and 15 months after the date of randomization.
  
  
  
  There were no between-arm differences in change scores on the RM-UWHNSS in the individual items, total score, or factor scores. For statistical modeling, race and time were significant for all outcomes (total and factor scores), while treatment arm was not significant. The ALTENS arm showed greater yet nonsignificant improvement in outcomes compared to the PC arm.
  
  
  
  Although no significant treatment differences were seen in this trial, patients receiving ALTENS consistently had lower scores, indicating better function, as compared to those receiving PC. Radiation-induced xerostomia improved over time for all patients.
authors.affiliation: College of Nursing, Michigan State University, 1355 Bogue St. Room C345, East Lansing, MI, 48824, USA. Gwen.Wyatt@hc.msu.edu.
authors.forename: Gwen
authors.initials: G
authors.lastname: Wyatt
authors.affiliation: NRG Oncology Statistics and Data Management Center, Philadelphia, PA, USA.
authors.forename: Stephanie L
authors.initials: SL
authors.lastname: Pugh
authors.affiliation: Juravinski Cancer Centre, Hamilton, ON, Canada.
authors.forename: Raimond K W
authors.initials: RK
authors.lastname: Wong
authors.affiliation: Juravinski Cancer Centre, Hamilton, ON, Canada.
authors.forename: Stephen
authors.initials: S
authors.lastname: Sagar
authors.affiliation: Roswell Park Cancer Institute, Buffalo, NY, USA.
authors.forename: Anurag K
authors.initials: AK
authors.lastname: Singh
authors.affiliation: Cleveland Clinic, Cleveland, OH, USA.
authors.forename: Shlomo A
authors.initials: SA
authors.lastname: Koyfman
authors.affiliation: Centre Hospitalier de l'Université de Montréal-Hôpital Notre-Dame, Montreal, QC, Canada.
authors.forename: Phuc F
authors.initials: PF
authors.lastname: Nguyen-Tân
authors.affiliation: University of California San Francisco, San Francisco, CA, USA.
authors.forename: Sue S
authors.initials: SS
authors.lastname: Yom
authors.affiliation: Yale-New Haven Hospital Saint Raphael Campus, New Haven, CT, USA.
authors.forename: Francis S
authors.initials: FS
authors.lastname: Cardinale
authors.affiliation: McGill University, Montreal, QC, Canada.
authors.forename: Khalil
authors.initials: K
authors.lastname: Sultanem
authors.affiliation: Juravinski Cancer Centre, Hamilton, ON, Canada.
authors.forename: Ian
authors.initials: I
authors.lastname: Hodson
authors.affiliation: University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.
authors.forename: Greg A
authors.initials: GA
authors.lastname: Krempl
authors.affiliation: John H. Stroger, Jr. Hospital of Cook County MB-CCOP, Chicago, IL, USA.
authors.forename: Barbara
authors.initials: B
authors.lastname: Lukaszczyk
authors.affiliation: Indiana University Hospital/Melvin and Bren Simon Cancer Center, Indianapolis, IN, USA.
authors.forename: Alexander M
authors.initials: AM
authors.lastname: Yeh
authors.affiliation: University of South Florida H. Lee Moffitt Cancer Center, Tampa, FL, USA.
authors.forename: Lawrence
authors.initials: L
authors.lastname: Berk
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006258:Head and Neck Neoplasms / Q000150:complications*; D006801:Humans; D008297:Male; D008495:Medical Oncology; D008875:Middle Aged; D011446:Prospective Studies; D018434:Sickness Impact Profile; D004561:Transcutaneous Electric Nerve Stimulation / Q000379:methods*; D014987:Xerostomia / Q000139:chemically induced / Q000523:psychology*
keywords: Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS); Head and neck cancer; Radiation-induced xerostomia (RIX); Symptom management