Name of the Trial
Randomized Pilot Study of Electroacupuncture for Chronic Radiation-induced Xerostomia in Patients with Head and Neck Cancer (MAYO-MCS285). See the protocol summary 1.
Why This Trial Is Important
Head and neck cancers are often treated with external-beam radiation therapy 2. Although this treatment can be effective in controlling head and neck tumors, it may cause side effects 3 that can compromise a patient’s quality of life. Chronic dry mouth, also called xerostomia, is common among patients treated with radiation to the head and neck. This condition results from damage to the glands that produce saliva. Chronic dry mouth can have a major impact 4 on quality of life by causing pain and discomfort, affecting the ability to sleep, altering taste, and/or increasing the likelihood of dental problems.
Some drugs are available for xerostomia induced by radiation therapy, but many patients experience only a partial improvement or no benefit at all. The drug amifostine 5 can help protect the salivary glands of some head and neck cancer patients from radiation damage, but this drug cannot be used in all patients.
Some studies have suggested that acupuncture 6 can help relieve the sensation of mouth dryness in cancer patients who have undergone head and neck radiation therapy. Based on these studies and other evidence, researchers at the Mayo Clinic in Scottsdale, AZ, are investigating the ability of a procedure called electroacupuncture to help improve the production of saliva and the quality of life of patients with chronic dry mouth. Electroacupuncture involves stimulating traditional acupuncture points 7 on the skin using small electrodes instead of needles inserted into the skin.
In this clinical trial, head and neck cancer patients with chronic dry mouth who completed radiation therapy at least 6 months before joining the trial and who received no benefit from treatment with the drug pilocarpine 8 (Salagen) will be randomly assigned to undergo electroacupuncture using a machine called a LISS stimulator, or a sham procedure using a similar-looking machine that does not produce electrical stimulation. Treatment will last for 4 weeks (20-minute sessions 5 days a week for the first 2 weeks, and then 3 days a week for the last 2 weeks) and will be administered at the Mayo Clinic in Scottsdale. Saliva flow, the patients’ subjective sensation of mouth dryness, and quality of life will be assessed during the first 3 weeks of treatment and then again 1, 3, and 6 months following treatment.
“Depending on the radiation techniques used and the location of the tumor, up to 90 percent of head and neck cancer patients receiving radiation therapy will experience chronic dry mouth,” said Dr. Halyard. “Electroacupuncture is a non-needle approach that uses electrical stimulation of the acupuncture points thought to control salivation. The hypothesis is that this stimulation will alter the energy flow of the acupuncture points and result in an increase in saliva production.
“To date, we have enrolled 24 of 30 patients for the study, so we have 6 slots left,” Dr. Halyard continued. “I would be happy to discuss the study with any patients who think they might be interested and who can commit a month to treatment in Scottsdale, as well as return for the three post-treatment assessments.” (See contact information link.)
1. Dr. Michele Haylard, Principal Investigator, Mayo Clinic Scottsdale
2. For more information:
See the lists of entry criteria 9 and trial contact information 10 or call the NCI’s Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The toll-free call is confidential.
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