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.

Public Health Relevance

The proposed study will examine the efficacy, duration of response, and mechanisms of acupuncture to reduce the severity of radiation-induced chronic xerostomia after completing radiotherapy for head and neck cancer. If we find that acupuncture reduces xerostomia and improves quality of life, then this type of treatment can be incorporated into the standard of care for treating radiation-induced xerostomia.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
1R01CA160880-01A1
Application #
8296964
Study Section
Behavioral Medicine, Interventions and Outcomes Study Section (BMIO)
Program Officer
O'Mara, Ann M
Project Start
2012-04-10
Project End
2016-03-31
Budget Start
2012-04-10
Budget End
2013-03-31
Support Year
1
Fiscal Year
2012
Total Cost
$468,070
Indirect Cost
$171,823
Name
University of Texas MD Anderson Cancer Center
Department
Internal Medicine/Medicine
Type
Other Domestic Higher Education
DUNS #
800772139
City
Houston
State
TX
Country
United States
Zip Code
77030