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
  Purpose

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.


Condition Intervention
Head and Neck Cancer
Radiation Toxicity
Xerostomia
Other: questionnaire administration
Procedure: electroacupuncture therapy
Procedure: management of therapy complications
Procedure: quality-of-life assessment

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Single Blind
Primary Purpose: Supportive Care
Official Title: Electroacupuncture for Xerostomia in Head and Neck Patients

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: February 2006
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
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 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.

  Eligibility

Ages Eligible for Study:   21 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623129

Locations
United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259-5499
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Michele Y Halyard, M.D. Mayo Clinic Mayo Clinic
  More Information

No publications provided

Responsible Party: Michele Yvette Halyard, M.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00623129     History of Changes
Other Study ID Numbers: CDR0000583031, P30CA015083, MCS285, 2327-05, NCI-2010-01835
Study First Received: February 22, 2008
Last Updated: August 10, 2011
Health Authority: United States: Federal Government

Keywords provided by Mayo Clinic:
hypopharyngeal cancer
lip and oral cavity cancer
laryngeal cancer
nasopharyngeal cancer
oropharyngeal cancer
paranasal sinus and nasal cavity cancer
salivary gland cancer
xerostomia
radiation toxicity

Additional relevant MeSH terms:
Head and Neck Neoplasms
Xerostomia
Radiation Injuries
Neoplasms by Site
Neoplasms
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on October 19, 2014