NCT00623129

Electroacupuncture in Treating Chronic Dry Mouth Caused By Radiation Therapy in Patients With Head and Neck Cancer

Electroacupuncture for Xerostomia in Head and Neck Patients

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 21 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Electroacupuncture may help relieve chronic dry mouth caused by radiation therapy. It is not yet known whether electroacupuncture is more effective than a placebo in treating chronic dry mouth caused by radiation therapy in patients with head and neck cancer. PURPOSE: This randomized clinical trial is studying electroacupuncture to see how well it works compared with a placebo in treating chronic dry mouth caused by radiation therapy in patients with head and neck cancer.

Detailed description

OBJECTIVES: * To determine if electrostimulation using the Liss stimulator can objectively improve salivary flow as measured by sialometry compared to a placebo device in patients with chronic radiation-induced xerostomia and head and neck cancer. * To determine if electrostimulation using the Liss Stimulator can improve the subjective sensation of mouth dryness compared to a placebo device. * To characterize the effect of electrostimulation using the Liss stimulator on quality of life compared to a placebo device. OUTLINE: Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo placement of electrodes to the following acupuncture points: stomach, liver, pericardium, small intestine, and large intestine. Patients then undergo electro-stimulation of the acupuncture points using the Liss Stimulator for 20 minutes once a day for 10 days and then 3 times a week for 2 weeks. * Arm II (placebo): Patients undergo placement of electrodes to the following acupuncture points: stomach, liver, pericardium, small intestine, and large intestine. A device that does not produce an electric current is placed over the electrodes for 20 minutes once a day for 10 days and then 3 times a week for 2 weeks. Patients complete questionnaires, including the Brief Pain Inventory, the Xerostomia Inventory, and a subscale of the University of Washington Head and Neck Symptom Scale, at baseline, on days 5 and 10 of treatment, and at 1, 3, and 6 months after completion of treatment. Sialometry (unstimulated and stimulated whole saliva measurement) is also performed at the same time points. After completion of study treatment, patients are followed at 1, 3, and 6 months.

Conditions

• Head and Neck Cancer
• Radiation Toxicity
• Xerostomia

Interventions

Type	Name	Description
OTHER	questionnaire administration
PROCEDURE	electroacupuncture therapy
PROCEDURE	management of therapy complications
PROCEDURE	quality-of-life assessment

Timeline

• Start date: 2006-02-01
• Primary completion: 2010-11-01
• First posted: 2008-02-25
• Last updated: 2016-04-19

Locations

1 site across 1 country: United States