Acupuncture for dysphagia after chemoradiation therapy in head and neck cancer: A randomized sham-controlled study.

6058 Background: Dysphagia is a common side effect following chemoradiation (CRT) in pts with head and neck cancer (HNC). The purpose of this pilot trial was to assess the feasibility of recruiting HNC pts and to collect preliminary data on the efficacy and safety of acupuncture on dysphagia-related QOL. Methods: Pts were eligible if diagnosed with stage III-IV HNC, without evidence of distance metastasis, receiving curative-intent CRT. Pts were randomized to 12 sessions of either active or sham acupuncture, once every two weeks, over 24 weeks from during CRT to 20-week post-CRT. All study personnel and the pts were blinded; the treating acupuncturists were not. MDADI and other questionnaires were measured at baseline (end of CRT), end of acupuncture, and at six months follow-up (12-month post-CRT). Data were analyzed by repeated-measures ANOVA adjusting for baseline. Results: Accrual was completed in December 2011. Among 42 pts enrolled, 35 (83%) received at least 8 sessions of acupuncture, and 28 (67%) received all 12. Six pts withdrew due to time constraints. No serious side effects were observed. The mean MDADI total scores improved from baseline in both treatment arms [64.5 (SE+2.4) vs. 71.4 (SE±3.1), p = 0.048; 64.5 (SE±2.4) vs. 77.8 (SE±3.0), p< 0.001]; the difference in improvement was not significant (p = 0.12). The median feeding tube duration did not differ between active and sham treatments (n = 39, median 125 days vs. 147 days, p = 0.93). Conclusions: Acupuncture is a safe and feasible treatment for HNC pts. There were improvements in QOL parameters from end of CRT to the time points examined that did not differ between the two arms. Efficacy of acupuncture to improve swallowing-related QOL in HNC pts may require more frequent or longer duration of treatment. Clinical trial information: NCT00797732.