Acupuncture Studied to Prevent Radiation-Induced Chronic Dry Mouth

Division of Cancer Prevention

Xerostomia, or chronic severe dry mouth, is caused by reduced salivary flow and is a common side effect for many patients receiving radiotherapy for head and neck cancers. Most of the current treatments for xerostomia are palliative and offer limited benefit, but studies have begun to show promising results for the use of acupuncture in preventing and lessening xerostomia.

NCI has supported two small studies, conducted at the MD An­derson Cancer Center and the Fudan University Cancer Hospital in Shanghai, China, that investigated the feasibility and efficacy of acupuncture as a potential preventive therapy for radiation-in­duced chronic dry mouth. Based on promising results from the previous studies*, NCI is currently funding** two large, random­ized, phase III trials that examine the effects of acupuncture for preventing or treating radiation-induced xerostomia.

Lorenzo Cohen, Ph.D., professor in the MD Anderson Departments of General Oncology and Behavioral Science and director of the cancer center’s Integrative Medicine Program, is the principal investigator of the grants, which have supported all of these acupuncture studies. He said the first phase III study, already well underway, is testing the use of acupuncture in preventing xerostomia in patients undergoing radiotherapy for head and neck cancer or nasopharyngeal carcinoma.

According to Dr. Cohen, the clinical trial compares active acupuncture with the use of a placebo or “sham” version of acupuncture, as well as with a third group of patients who will receive usual medical care. Each of the three arms of the study will enroll 100 patients, divided evenly between MD Anderson and the Fudan Hospital.

Patients in the two acupuncture groups (active and sham) are treated 3 times weekly during the 7 weeks they receive radiation therapy. The comparison with sham acupuncture is important, Dr. Cohen explained, because some previous studies have found that “you often don’t see any clinical differences between the two approaches although both of them are usually better than usual care alone.” Both types of acupuncture treatments used in the study involve “combinations of real needles and sham needles (blunt needles that touch the skin then retract into their handles),” he explained. “This is something we’re not telling our patients in the study so that we can keep them ‘blinded’ about which acupuncture treatment they’re receiving.”

The study is evaluating the patients’ self-reported outcomes based on a xerostomia questionnaire, which assesses severity of dry mouth symptoms and their interference with quality of life. In addition, Dr. Cohen and his colleagues are measuring saliva flow rates using standardized sialometry collection techniques. “We’ll also be looking at the constituents of the saliva, such as pH, buffering capacity, viscosity, and the different proteins that are in the saliva,” he noted. Patient assessments occur at baseline, mid- and immediately post- radiation treatment, as well as at 3, 6, and 12 months following treatment.

The second major research study of acupuncture (active and sham) and xerostomia will start later in 2012 in over a dozen institutions around the United States that are part of the NCI’s Community Clinical Oncology Program (CCOP) network. The study will examine the effects of acupuncture to reduce the severity of radiation-induced xerostomia in patients with chronic xerostomia who have already completed radiotherapy for head and neck cancer.

“I’m hoping – if these two large, well-designed clinical trials confirm our earlier positive findings – that the use of acupuncture for the prevention and treatment of xerostomia will become the standard of care for this debilitating problem,” Dr. Cohen commented. He added that he hopes these studies will also clear the way for health insurance coverage of the treatment. However, he noted, if the studies show that active and sham acupuncture produce equivalent results and are both better than usual care, that will open up areas of additional research to determine the reasons for those similarities.