title: Acupuncture for dysphagia after chemoradiation in head and neck cancer: rationale and design of a randomized, sham-controlled trial.
abstract: BACKGROUND
  Dysphagia is a common side effect following chemoradiation therapy (CRT) in head and neck cancer (HNC) patients. Current dysphagia management includes swallowing therapy and dilation procedures, but these treatments have limitations. While acupuncture has been reported to positively impact swallowing function and quality of life (QOL) in patients with dysphagia, current evidence is inconclusive.
  
  
  METHODS
  In an ongoing trial, 42 squamous cell carcinoma HNC patients, who are receiving platinum-based CRT with curative intent, are being recruited from a comprehensive cancer center. They are randomized to 12 sessions of either active acupuncture or to sham acupuncture during and following CRT over a 24-week period. Blinded research staff assesses outcomes at baseline, 20 weeks post-CRT (end of acupuncture), and 12 months after baseline (6-month follow-up). The primary outcome is change in M.D. Anderson Dysphagia Inventory score from baseline to 12 months. Secondary outcomes include QOL measures pertaining to HNC patients. In addition, a subset of study patients are tested for salivary flow rates and cytokines, including plasma transforming growth factor-β1 and interleukin 6 (n=10 per arm), to preliminarily explore the biological mechanisms of acupuncture for dysphagia.
  
  
  CONCLUSIONS
  This paper addresses unique challenges related to study design in nonpharmacological, sham-controlled acupuncture trials including development of evidence-based credible verum and sham treatment protocols, blinding, and assuring fidelity of treatment. Results of this study will inform the feasibility of conducting a large scale trial and will provide preliminary evidence regarding the value of acupuncture for dysphagia in HNC patients.
authors.affiliation: Leonard P. Zakim Center for Integrative Therapies, Dana-Farber Cancer Institute, Boston, MA 02215, USA. weidong_lu@dfci.harvard.edu
authors.forename: Weidong
authors.initials: W
authors.lastname: Lu
authors.forename: Peter M
authors.initials: PM
authors.lastname: Wayne
authors.forename: Roger B
authors.initials: RB
authors.lastname: Davis
authors.forename: Julie E
authors.initials: JE
authors.lastname: Buring
authors.forename: Hailun
authors.initials: H
authors.lastname: Li
authors.forename: Laura A
authors.initials: LA
authors.lastname: Goguen
authors.forename: David S
authors.initials: DS
authors.lastname: Rosenthal
authors.forename: Roy B
authors.initials: RB
authors.lastname: Tishler
authors.forename: Marshall R
authors.initials: MR
authors.lastname: Posner
authors.forename: Robert I
authors.initials: RI
authors.lastname: Haddad
mesh_terms: D015670:Acupuncture Therapy; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002294:Carcinoma, Squamous Cell / Q000628:therapy*; D059248:Chemoradiotherapy / Q000009:adverse effects*; D002985:Clinical Protocols; D003680:Deglutition Disorders / Q000209:etiology / Q000628:therapy*; D004311:Double-Blind Method; D005240:Feasibility Studies; D006258:Head and Neck Neoplasms / Q000628:therapy*; D006801:Humans; D008875:Middle Aged; D010352:Patient Dropouts; D018579:Patient Selection; D010865:Pilot Projects; D011788:Quality of Life; D012107:Research Design; D016896:Treatment Outcome; D055815:Young Adult