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Title: Acupuncture-Like Transcutaneous Electrical Nerve Stimulation Versus Pilocarpine in Treating Radiation-Induced Xerostomia: Results of RTOG 0537 Phase 3 Study

Purpose and Objectives: This report presents the analysis of the RTOG 0537 multicenter randomized study that compared acupuncture-like transcutaneous stimulation (ALTENS) with pilocarpine (PC) for relieving radiation-induced xerostomia. Methods and Materials: Eligible patients were randomized to twice-weekly 20-minute ALTENS sessions for 24 sessions during 12 weeks or PC (5 mg 3 times daily for 12 weeks). The primary endpoint was the change in the University of Michigan Xerostomia-Related Quality of Life Scale (XeQOLS) scores from baseline to 9 months from randomization (MFR). Secondary endpoints included basal and citric acid primed whole salivary production (WSP), ratios of positive responders (defined as patients with ≥20% reduction in overall radiation-induced xerostomia symptom burden), and the presence of adverse events based on the Common Terminology Criteria for Adverse Events version 3. An intention-to-treat analysis was conducted. Results: One hundred forty-eight patients were randomized. Only 96 patients completed the required XeQOLS and were evaluable at 9 MFR (representing merely 68.6% statistical power). Seventy-six patients were evaluable at 15 MFR. The median change in the overall XeQOLS in ALTENS and PC groups at 9 and 15 MFR were −0.53 and −0.27 (P=.45) and −0.6 and −0.47 (P=.21). The corresponding percentages of positive responders were 81% and 72% (P=.34) and 83%more » and 63% (P=.04). Changes in WSP were not significantly different between the groups. Grade 3 or less adverse events, mostly consisting of grade 1, developed in 20.8% of patients in the ALTENS group and in 61.6% of the PC group. Conclusions: The observed effect size was smaller than hypothesized, and statistical power was limited because only 96 of the recruited 148 patients were evaluable. The primary endpoint—the change in radiation-induced xerostomia symptom burden at 9 MFR—was not significantly different between the ALTENS and PC groups. There was significantly less toxicity in patients receiving ALTENS.« less
Authors:
 [1] ;  [2] ;  [3] ;  [1] ;  [4] ;  [5] ;  [6] ;  [7] ;  [8] ;  [9] ;  [1] ;  [10] ;  [11] ;  [12] ;  [2] ;  [13]
  1. McMaster University, Juravinski Cancer Centre, Hamilton, Ontario (Canada)
  2. NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania (United States)
  3. Michigan State University, East Lansing, Michigan (United States)
  4. Roswell Park Cancer Institute, Buffalo, New York (United States)
  5. McGill University, Montreal, Quebec (Canada)
  6. Centre Hospitalier de l'Université de Montréal-Hôpital Notre-Dame, Montreal, Quebec (Canada)
  7. University of California San Francisco, San Francisco, California (United States)
  8. Yale-New Haven Hospital Saint Raphael Campus, New Haven, Connecticut (United States)
  9. University Hospitals of Cleveland, Cleveland, Ohio (United States)
  10. University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma (United States)
  11. Cleveland Clinic Foundation, Cleveland, Ohio (United States)
  12. John H. Stroger, Jr. Hospital of Cook County MB-CCOP, Chicago, Illinois (United States)
  13. University of South Florida H. Lee Moffitt Cancer Center, Tampa, Florida (United States)
Publication Date:
OSTI Identifier:
22458712
Resource Type:
Journal Article
Resource Relation:
Journal Name: International Journal of Radiation Oncology, Biology and Physics; Journal Volume: 92; Journal Issue: 2; Other Information: Copyright (c) 2015 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved.; Country of input: International Atomic Energy Agency (IAEA)
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; ACUPUNCTURE; CITRIC ACID; COMPARATIVE EVALUATIONS; EDUCATIONAL FACILITIES; MICHIGAN; PATIENTS; PILOCARPINE; STANDARD OF LIVING; STIMULATION; SYMPTOMS; TOXICITY