Status:
TERMINATED
Electroacupuncture in Treating Chronic Dry Mouth Caused By Radiation Therapy in Patients With Head and Neck Cancer
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Head and Neck Cancer
Radiation Toxicity
Eligibility:
All Genders
21-89 years
Phase:
NA
Brief 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 mo...
Detailed 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 radiat...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00623129
Start Date
February 1 2006
Last Update
April 19 2016
Active Locations (1)
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1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259-5499