Grant R01CA148707

Placebo Controlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia

DESCRIPTION (provided by applicant): Xerostomia (dry mouth) is an important and common problem among cancer patients who have received radiation treatment to the head and neck area. Xerostomia often severely impairs patients'quality of life (QOL), and current available treatments have a low success rate. Studies have been conducted in the United States and Europe suggesting that acupuncture is useful for treating radiation-induced xerostomia. Less research has examined the use of acupuncture at preventing the severity of radiation- induced xerostomia and examining the duration of response. Initial research conducted at The University of Texas M. D. Anderson Cancer Center and collaborative research at Fudan University Cancer Hospital in Shanghai, China found that acupuncture can diminish symptoms in patients who had already developed xerostomia and could prevent the severity of xerostomia symptoms and improve QOL in patients undergoing radiotherapy. The proposed multi-center, randomized, placebo-controlled trial will examine the effects of acupuncture at preventing radiation-induced xerostomia in patients undergoing radiotherapy for head and neck cancer (M. D. Anderson) or nasopharyngeal carcinoma (NPC) (Fudan Cancer Hospital). Prior to receiving radiation treatment, patients will be randomized to one of three groups: true acupuncture;sham acupuncture;or standard care. Subjective and objective measures of xerostomia will be collected prior to, during, and at the end of the radiation treatment, as well as 3, 6, and 12 months later. The aims of this study are to: 1. Determine if true acupuncture is more effective than sham acupuncture or standard care for preventing the severity and incidence of radiation-induced xerostomia;2. Examine group differences in salivary flow rates using unstimulated and stimulated whole saliva flow rates;3. Examine whether true acupuncture results in better overall QOL than sham acupuncture or standard of care;4. Determine the effects of acupuncture on saliva-based constituents as potential mechanisms;and 5. Examine the role of expectancy for the benefits of acupuncture in predicting outcomes. The role of expectancy as a moderator of the effects of treatment will be thoroughly examined.