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

Head and Neck Cancer Clinical Trial

Official title:

Electroacupuncture for Xerostomia in Head and Neck Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00623129
• Other study ID #: CDR0000583031
• Secondary ID: P30CA015083MCS28
• Status: Terminated
• Phase: N/A
• First received: February 22, 2008
• Last updated: April 18, 2016
• Start date: February 2006

Study information

• Verified date: August 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 89 Years

Eligibility

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)

Study Design

Allocation: Randomized, Masking: Single Blind, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Radiation Injuries
• Radiation Toxicity
• Xerostomia

Intervention

Other:
• questionnaire administration

Procedure:
• electroacupuncture therapy

• management of therapy complications

• quality-of-life assessment

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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			No
Primary	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			No
Primary	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			No