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 range

21 Years – 89 Years

Sex

ALL

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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