Neoplasms

All Conditions

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Head and Neck Neoplasms

Nasopharyngeal Carcinoma

Xerostomia

Mouth Neoplasms

Salivary Gland Diseases

Mouth Diseases

Stomatognathic Diseases

Chronic Graft Versus Host Disease

Oral Cancer

Laryngeal Cancer

Hypopharyngeal Cancer

Lip and Oral Cavity Cancer

questionnaire administration

electroacupuncture therapy

management of therapy complications

quality-of-life assessment

Michele Y Halyard, M.D.

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.

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

National Cancer Institute (NCI)

Mayo Clinic

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Electroacupuncture in Treating Chronic Dry Mouth Caused By Radiation Therapy in Patients With Head and Neck Cancer	NCT00623129	Head and Neck C... Radiation Toxic... Xerostomia	questionnaire a... electroacupunct... management of t... quality-of-life...	21 Years - 89 Years	Mayo Clinic
Electroacupuncture in Treating Chronic Dry Mouth Caused By Radiation Therapy in Patients With Head and Neck Cancer	NCT00623129	Head and Neck C... Radiation Toxic... Xerostomia	questionnaire a... electroacupunct... management of t... quality-of-life...	21 Years - 89 Years	Mayo Clinic

Spots Global Cancer Trial Database for electroacupuncture therapy