Acupuncture for dysphagia after chemoradiation therapy in head and neck cancer: An ongoing pilot, randomized, sham-controlled trial.

Abstract

TPS270 Background: Dysphagia is a common side effect following chemoradiation therapy (CRT) in patients with head and neck cancer (HNC). Dysphagia and other treatment-related conditions such as aspiration, xerostomia, and fibrosis can significantly impact quality of life (QOL) in HNC patients. Acupuncture could potentially impact dysphagia by improving salivary production, restoring swallowing reflex, and inhibiting the fibrosis process. Preliminary clinical studies suggest that acupuncture may improve radiation–induced xerostomia in HNC patients. However, acupuncture has not been rigorously tested for dysphagia in HNC patients in a randomized controlled trial. The purpose of the ongoing pilot, randomized, sham-controlled trial is to assess the feasibility of recruiting and retaining HNC patients, and to collect preliminary data on the efficacy and safety of acupuncture on dysphagia and health-related quality of life (QOL). Methods: Eligible participants are patients diagnosed with squamous cell carcinoma of the head and neck at stage II, III and IV, without evidence of distant metastasis, receiving chemoradiation. They are randomized to 12 sessions of either active acupuncture (n=18) or sham acupuncture (n=18). All study personnel and study participants, except the treating acupuncturist, are blinded to the treatment assignment. The active acupuncture consists of manual and electro stimulation at extremities, while sham acupuncture needles are placed at adjacent sites with a mock stimulation device. The primary endpoint of the study is to assess the feasibility of recruiting and retaining HNC patients into a randomized controlled trial of acupuncture. The study will be considered feasible for further study if at least 75% of intervention participants are compliant and at least 80% of participants in each group complete all study evaluations. Secondary end points include: The M. D. Anderson Dysphagia Inventory and other QOL questionnaires are measured periodically during the treatment and a 6 months following up period. The planned study recruitment period is from January 2008 to December 2010. Seven patients have been enrolled into the study as of January 2010. No significant financial relationships to disclose.