INTRODUCTION: @entity1282 is a common side effect following chemoradiation therapy (CRT) in @entity135 ( @entity135 ) @entity1 . Current @entity1282 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 @entity1 with @entity1282 , current evidence is inconclusive. MATERIAL AND METHODS: In an ongoing trial, 42 @entity957 @entity135 @entity1 , who are receiving @entity902 -based CRT with curative intent, are being recruited from a comprehensive @entity5 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 @entity1282 Inventory score from baseline to 12 months. Secondary outcomes include QOL measures pertaining to @entity135 @entity1 . In addition, a subset of study @entity1 are tested for salivary flow rates and cytokines, including plasma @entity2533 and @entity650 (n=10 per arm), to preliminarily explore the biological mechanisms of acupuncture for @entity1282 . DISCUSSION: 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 @entity1282 in @entity135 @entity1 .

Acupuncture for @entity1282 after chemoradiation in XXXX : rationale and design of a randomized, sham-controlled trial.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity135 :: ('MESH:D006258', 'Disease') :: ['head and neck cancer', 'HNC'] @entity650 :: ('3569', 'Gene') :: ['interleukin 6'] @entity5 :: ('MESH:D009369', 'Disease') :: ['cancer'] @entity957 :: ('MESH:D002294', 'Disease') :: ['squamous cell carcinoma'] @entity2533 :: ('7040', 'Gene') :: ['transforming growth factor-b1'] @entity1282 :: ('MESH:D003680', 'Disease') :: ['Dysphagia', 'dysphagia'] @entity902 :: ('MESH:D010984', 'Chemical') :: ['platinum']
@entity135 :: (MESH:D006258,Disease) :: ['head and neck cancer']
