Head and Neck Cancer Clinical Trial
Official title:
Electroacupuncture for Xerostomia in Head and Neck Patients
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.
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.
;
Allocation: Randomized, Masking: Single Blind, Primary Purpose: Supportive Care
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