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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Electroacupuncture for Xerostomia in Head and Neck Patients

Conditions
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Head and Neck Cancer, Radiation Toxicity, Xerostomia

Intervention / Treatment
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* Other: questionnaire administration
* Procedure: electroacupuncture therapy
* Procedure: management of therapy complications
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of primary head and neck cancer Has undergone radiotherapy either as primary or adjuvant therapy ≥ 6 months ago One or more parotid glands must have been in the prior radiotherapy field Residual xerostomia after radiotherapy deemed to be significant by patient Failed to respond to a trial of pilocarpine for relief of xerostomia PATIENT CHARACTERISTICS: ECOG performance status 0-3 Life expectancy ≥ 1 year (based on physician's judgment) Able to attend the scheduled study treatments Alert and mentally competent Not pregnant Willing to use contraception during study treatment, if of childbearing age No history of Sjögren's disease No cardiac pacemaker or any other electrical devices permanently implanted within the body (e.g., dorsal column stimulator) PRIOR CONCURRENT THERAPY: See Disease Characteristics More than 2 weeks since prior medication that may cause mouth dryness (e.g., antihistamines, narcotics, tricyclic antidepressants)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: questionnaire administration|nan|
|Procedure: electroacupuncture therapy|nan|
|Procedure: management of therapy complications|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary flow as measured by sialometry at baseline, on days 5 and 10 of treatment, and at 1, 3, and 6 months after completion of treatment |  |  | 
| Subjective sensation of mouth dryness as measured by quality of life questionnaires at baseline, on days 5 and 10 of treatment, and at 1, 3, and 6 months after completion of treatment |  |  | 
| Quality of life as measured by quality of life questionnaires at baseline, on days 5 and 10 of treatment, and at 1, 3, and 6 months after completion of treatment |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypopharyngeal cancer, lip and oral cavity cancer, laryngeal cancer, nasopharyngeal cancer, oropharyngeal cancer, paranasal sinus and nasal cavity cancer, salivary gland cancer, xerostomia, radiation toxicity