PMID- 27511906 OWN - NLM STAT- MEDLINE DCOM- 20171103 LR - 20220330 IS - 1549-490X (Electronic) IS - 1083-7159 (Print) IS - 1083-7159 (Linking) VI - 21 IP - 12 DP - 2016 Dec TI - Acupuncture for Chemoradiation Therapy-Related Dysphagia in Head and Neck Cancer: A Pilot Randomized Sham-Controlled Trial. PG - 1522-1529 AB - INTRODUCTION: Dysphagia is common in head and neck cancer patients after concurrent chemoradiation therapy (CRT). This study evaluated the feasibility of conducting a randomized sham-controlled trial and collected preliminary data on safety and efficacy of acupuncture. PATIENTS AND METHODS: Head and neck cancer (HNC) patients with stage III-IV squamous cell carcinoma were randomized to 12 sessions of either active acupuncture (AA) or sham acupuncture (SA) during and following CRT. Patients were blinded to treatment assignment. Swallowing-related quality of life (QOL) was assessed using the MD Anderson Dysphagia Inventory (MDADI) total and subscale scores. RESULTS: Multiple aspects of trial feasibility were confirmed. Forty-two of 196 patients screened (21%) were enrolled and randomized to receive AA (n = 21) or SA (n = 21); 79% completed at least 10 of 12 planned acupuncture sessions; 81% completed the study follow-ups. The majority of patients reported uncertainty regarding their treatment assignment, with no difference between the AA and SA groups. Audits confirmed both AA and SA treatments were delivered with high fidelity. No serious acupuncture-related side effects were observed. MDADI total scores significantly improved from baseline to 12 months post-CRT in both groups (AA: +7.9; SA +13.9; p = .044, p < .001). Similar patterns were observed for the MDADI global subscale (AA: +25.0; SA +22.7; p = .001, p = .002). Intent-to-treat analyses suggested no difference between the treatment groups (p = .17, p = .76 for MDADI total and global scores, respectively). CONCLUSION: A sham-controlled randomized trial evaluating acupuncture in dysphagia-related QOL in HNC found the procedure to be feasible and safe. Further investigation is required to evaluate efficacy. IMPLICATIONS FOR PRACTICE: Dysphagia or swallowing difficulty is an important and common condition after concurrent chemoradiation therapy in head and neck cancer patients. In addition to current available supportive care, acupuncture may offer potential for treating dysphagia. This study demonstrated that both active acupuncture and sham acupuncture are safe and were associated with improved dysphagia-related quality of life from baseline to 12 months after concurrent chemoradiation therapy. This study was not designed to inform underlying specific versus nonspecific effects. Future larger-scale pragmatic clinical trials evaluating the effectiveness of acupuncture versus standard of care are warranted, and further mechanistic research is needed to understand how active versus purportedly sham acupuncture procedures affect dysphagia-related symptoms. CI - (c)AlphaMed Press. FAU - Lu, Weidong AU - Lu W AD - Leonard P. Zakim Center for Integrative Therapies, Dana-Farber Cancer Institute, Boston, Massachusetts, USA weidong_lu@dfci.harvard.edu. FAU - Wayne, Peter M AU - Wayne PM AD - Osher Center for Integrative Medicine, Division of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA. FAU - Davis, Roger B AU - Davis RB AD - Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA. FAU - Buring, Julie E AU - Buring JE AD - Osher Center for Integrative Medicine, Division of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA. FAU - Li, Hailun AU - Li H AD - Dana-Farber/Harvard Cancer Center, Boston, Massachusetts, USA. FAU - Macklin, Eric A AU - Macklin EA AD - Biostatistics Center, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA. FAU - Lorch, Jochen H AU - Lorch JH AD - Head and Neck Oncology Program, Dana-Farber Cancer Institute, Boston, Massachusetts, USA. FAU - Burke, Elaine AU - Burke E AD - Head and Neck Oncology Program, Dana-Farber Cancer Institute, Boston, Massachusetts, USA. FAU - Haddad, Tyler C AU - Haddad TC AD - Head and Neck Oncology Program, Dana-Farber Cancer Institute, Boston, Massachusetts, USA. FAU - Goguen, Laura A AU - Goguen LA AD - Head and Neck Oncology Program, Dana-Farber Cancer Institute, Boston, Massachusetts, USA. FAU - Rosenthal, David S AU - Rosenthal DS AD - Leonard P. Zakim Center for Integrative Therapies, Dana-Farber Cancer Institute, Boston, Massachusetts, USA. FAU - Tishler, Roy B AU - Tishler RB AD - Head and Neck Oncology Program, Dana-Farber Cancer Institute, Boston, Massachusetts, USA. AD - Department of Radiation Oncology, Dana-Farber Cancer Institute/Brigham and Women's Hospital, Boston, Massachusetts, USA. FAU - Posner, Marshall R AU - Posner MR AD - Head and Neck Oncology Program, Dana-Farber Cancer Institute, Boston, Massachusetts, USA. AD - Head and Neck Oncology Center, Mount Sinai Medical Center, New York, New York, USA. FAU - Haddad, Robert I AU - Haddad RI AD - Head and Neck Oncology Program, Dana-Farber Cancer Institute, Boston, Massachusetts, USA. LA - eng GR - K01 AT004415/AT/NCCIH NIH HHS/United States PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, N.I.H., Extramural PT - Research Support, Non-U.S. Gov't DEP - 20160810 PL - England TA - Oncologist JT - The oncologist JID - 9607837 SB - IM MH - *Acupuncture Therapy/adverse effects MH - Aged MH - Chemoradiotherapy/*adverse effects MH - Deglutition Disorders/etiology/psychology/*therapy MH - Female MH - Head and Neck Neoplasms/pathology/*therapy MH - Humans MH - Male MH - Middle Aged MH - Pilot Projects MH - Quality of Life PMC - PMC5153334 OTO - NOTNLM OT - Acupuncture OT - Chemoradiation OT - Dysphagia OT - Head and neck cancers OT - Quality of life COIS- of potential conflicts of interest may be found at the end of this article. EDAT- 2016/08/12 06:00 MHDA- 2017/11/04 06:00 PMCR- 2017/12/01 CRDT- 2016/08/12 06:00 PHST- 2015/12/31 00:00 [received] PHST- 2016/06/14 00:00 [accepted] PHST- 2016/08/12 06:00 [pubmed] PHST- 2017/11/04 06:00 [medline] PHST- 2016/08/12 06:00 [entrez] PHST- 2017/12/01 00:00 [pmc-release] AID - theoncologist.2015-0538 [pii] AID - T15538 [pii] AID - 10.1634/theoncologist.2015-0538 [doi] PST - ppublish SO - Oncologist. 2016 Dec;21(12):1522-1529. doi: 10.1634/theoncologist.2015-0538. Epub 2016 Aug 10.