or
forgot password

Electroacupuncture for Xerostomia in Head and Neck Patients


N/A
21 Years
89 Years
Not Enrolling
Both
Head and Neck Cancer, Radiation Toxicity, Xerostomia

Thank you

Trial Information

Electroacupuncture for Xerostomia in Head and Neck Patients


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.

Inclusion 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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Single Blind, Primary Purpose: Supportive Care

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

Safety Issue:

No

Principal Investigator

Michele Y Halyard, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000583031

NCT ID:

NCT00623129

Start Date:

February 2006

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • Radiation Toxicity
  • Xerostomia
  • 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
  • Head and Neck Neoplasms
  • Xerostomia
  • Radiation Injuries

Name

Location
Mayo Clinic in Arizona Scottsdale, Arizona  85259-5404