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

This study has been terminated.
(Slow accrual; did not meet accrual goal)
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00623129
First received: February 22, 2008
Last updated: August 10, 2011
Last verified: August 2011

February 22, 2008
August 10, 2011
February 2006
November 2010   (final data collection date for primary outcome measure)
  • 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 [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00623129 on ClinicalTrials.gov Archive Site
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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

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.

Interventional
Not Provided
Allocation: Randomized
Masking: Single Blind
Primary Purpose: Supportive Care
  • Head and Neck Cancer
  • Radiation Toxicity
  • Xerostomia
  • Other: questionnaire administration
  • Procedure: electroacupuncture therapy
  • Procedure: management of therapy complications
  • Procedure: quality-of-life assessment
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
30
Not Provided
November 2010   (final data collection date for primary outcome measure)

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)
Both
21 Years to 89 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00623129
CDR0000583031, P30CA015083, MCS285, 2327-05, NCI-2010-01835
Yes
Michele Yvette Halyard, M.D., Mayo Clinic Cancer Center
Mayo Clinic
National Cancer Institute (NCI)
Study Chair: Michele Y Halyard, M.D. Mayo Clinic Mayo Clinic
Mayo Clinic
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP