A Pilot Randomized Controlled Trial to Evaluate the Efficacy and Explore the Mechanism of Acupuncture in Reducing the Severity of Chemoradiation-induced Mucositis in Patients With Oropharyngeal Cancer.

This is a single-center, randomized controlled pilot clinical trial (n=20) assessing the efficacy, feasibility and safety of acupuncture in reducing the severity of chemoradiation-induced oral mucositis (CRIOM) in patients with oropharyngeal cancer. Participants will be randomized to receive either usual medical care or acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16). All subjects will receive usual medical care in addition to the study intervention. The Oral Mucositis Daily Questionnaire for Head and Neck Cancer patients (OMDQ) will be used to assess patients' self-reported chemoradiation-induced mucositis severity at baseline (before 1st acupuncture session), and daily throughout the course of radiation, as well as at the 12 and 16 week follow up visits. At baseline, weekly during radiation therapy, and at the 12 and 16 week follow up appointments, patients will complete the Functional Assessment of Cancer Therapy (FACT-G), Esophagus Cancer subscale (ESC) QOL, and the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue subscale questionnaires. Oral mucositis will also be assessed objectively by a trained member of the research team using both the Oral Mucositis Assessment Scale (OMAS) and the National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE) v3.0 measurement scale once a week for the first two weeks of chemoradiation treatment, then twice a week during weeks three through seven, and additionally once during week 8 and once at the 12 and 16 week follow up visits. Twice weekly measurements correspond to peak severity of mucositis during weeks three to seven, based on previous reports in the literature. Patients will be given a weekly diary to record oral analgesic intake. Lastly, 8 milliliters of blood and a saliva sample will be taken from the subjects at baseline (before 1st acupuncture session), weekly through radiation treatment, and at the week 12 and 16 follow up visits to measure changes in proinflammatory cytokines concentrations.