Principal Investigator

Lorenzo
Cohen
Awardee Organization

University Of Tx Md Anderson Can Ctr
United States

Fiscal Year
2017
Activity Code
R01
Project End Date

Community-Based, Phase III Trial of acupuncture to treat chronic Xerostomia

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. Many of these trials were small with methodological weaknesses, few studies have investigated the putative mechanisms, and none were conducted at multiple centers. Initial research conducted at The University of Texas MD 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, community-based, randomized, placebo-controlled trial will examine the effects of acupuncture to reduce the severity of radiation-induced xerostomia in patients with chronic xerostomia after completing radiotherapy for head and neck cancer. At least 9 months after completing radiotherapy, 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 and after treatment, as well as 1 and 6 months later. The aims of this study are to: 1. Determine if true acupuncture is more effective than sham acupuncture or standard care for reducing the severity of radiation-induced xerostomia; 2. Explore the duration of response in patients who report an initial response to the acupuncture intervention; 3. Examine group differences in saliva flow using an objective measure of salivary function; 4. Examine whether true acupuncture results in better overall QOL than sham acupuncture or standard of care; 5. Determine the effects of acupuncture on saliva based factors including pH, buffering capacity, and viscosity as well as levels of total protein, calcitonin- gene-related peptide (CGRP), and vasoactive intestinal polypeptide (VIP); and 6. 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.

Publications

  • Garcia MK, Graham-Getty L, Haddad R, Li Y, McQuade J, Lee RT, Spano M, Cohen L. Systematic review of acupuncture to control hot flashes in cancer patients. Cancer. 2015 Nov 15;121(22):3948-58. Epub 2015 Aug 17. PMID: 26281028
  • Somogyi-Ganss E, Chambers MS, Lewin JS, Tarrand JJ, Hutcheson KA. Biofilm on the tracheoesophageal voice prosthesis: considerations for oral decontamination. European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery. 2017 Jan;274(1):405-413. Epub 2016 Jul 11. PMID: 27400694
  • Rosenthal DI, Mohamed ASR, Garden AS, Morrison WH, El-Naggar AK, Kamal M, Weber RS, Fuller CD, Peters LJ. Final Report of a Prospective Randomized Trial to Evaluate the Dose-Response Relationship for Postoperative Radiation Therapy and Pathologic Risk Groups in Patients With Head and Neck Cancer. International journal of radiation oncology, biology, physics. 2017 Aug 1;98(5):1002-1011. Epub 2017 Jul 10. PMID: 28721881