Clinical trial NCT00623129: Electroacupuncture in Treating Chronic Dry Mouth Caused By Radiation Therapy in Patients With Head and Neck Cancer
Official title: Electroacupuncture for Xerostomia in Head and Neck Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Head and Neck Cancer
Radiation Toxicity
Xerostomia
Keywords: 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
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-02-25
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: SUPPORTIVE_CARE

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 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.

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 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)

Primary outcomes:
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
measure: 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
measure: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic Mayo Clinic
name: Michele Y Halyard, M.D.
role: STUDY_CHAIR
References: