TerminatedNot Applicable

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

Stopped: Slow accrual; did not meet accrual goal

United States30 participantsStarted 2006-02

Plain-language 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.

Who can participate

Age range21 Years – 89 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

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

Trial details

NCT IDNCT00623129

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-11

View on ClinicalTrials.gov More Head and Neck Cancer trials