Dysphagia is a common side effect following chemoradiation therapy (CRT) in patients with head and neck cancer (HNC). It occurs in up to 50% of patients post CRT and results in poor general health and poor quality of life (QOL). There is growing evidence that acupuncture may be a safe and cost-effective adjunctive therapy to improve swallowing function and QOL in HNC patients. However, rigorous studies are few. This proposed K01 will provide the necessary training, skills, and experience for Dr. Weidong Lu, an acupuncturist with a strong background in complementary and alternative medicine (CAM) and some experience in acupuncture trials in oncology, to conduct clinical research regarding the effect of acupuncture on dysphagia following CRT in HNC patients. His long-term goal is to become an established independent investigator in the field of CAM research, specifically, to specialize in the conduct of sound clinical trials that evaluate the efficacy and safety of acupuncture as an adjunctive or integrative therapy for oncology-related conditions and symptoms. Immediate goals toward this end are, through a rigorous program of didactic training and research, to: 1) enhance his understanding and skills related to clinical trial design and conduct;2) strengthen his statistical and analytic skills, including those related to meta-analysis, outcomes research, survival analysis and biomarkers in oncology;and 3) improve his substantive knowledge of clinical oncology, especially of HNC. The candidate has assembled a strong committee of mentors with extensive expertise in each of these disciplines, who will guide his activities and progress throughout the award period. The training program will include regular meetings with sponsors, coupled with participation in selected courses, tutorials, seminars, professional meetings and research practice. Dr. Lu will conduct two pilot studies that will comprise the focus of his K01 award and the basis for at least one subsequent R01 grant application to be submitted within the award period. Using a randomized trial design, Dr. Lu will investigate the feasibility and efficacy of a 12-week acupuncture program on dysphagia in post CRT HNC patients, as well as explore the mechanism of acupuncture's effects in a subgroup of patients. The proposed studies will yield important information on the potential utility of acupuncture as an adjunctive therapy for improving dysphagia and QOL in HNC patients.
