IRB Number:

2327-05

Trial Status:

Open for Enrollment

Phase: II

Why is this study being done?

This study is being done to:
- To find out if electrostimulation with a Liss stimulator can improve salivary flow,
- To determine if electrostimulation using the Liss Stimulator can improve the sensation of mouth dryness in patients with chronic radiation-induced xerostomia (dry mouth); and
- To learn if electrostimulation with the Liss stimulator has an effect on quality of life

Who is Eligible to Participate in the Study?

-Age 21 years or older
-Diagnosis of primary head and neck cancer and have received radiotherapy
-Dry mouth after radiotherapy deemed to be significant by patient
-Patients are a minimum of six months post radiotherapy treatment
-Patient failed to respond to trial of Salagen for relief of dry mouth

*More specific, detailed eligibility and/ or exclusion criteria are associated with this trial.

What is Involved With this Study?

After the doctor determines whether the patient is eligible to take part in this study, patients will be put into one of two groups by chance (like the flip of a coin). Their treatment will consist of the placement of either the Liss stimulator or a device which looks identical to the Liss stimulator (a placebo device) but does not deliver the electroacupuncture treatments. The Liss stimulator is approved by the U.S. Food and Drug Administration (FDA) for delivery of electroacupuncture, but it is not FDA approved for the relief of dry mouth. The Liss stimulator or placebo device will be on several places, corresponding to acupuncture points, on the patient's body in the area outside the ear and side of the face. These areas will be treated for 20 minutes using the Liss Stimulator. The patient will not know which is the placebo treatment and which is delivered with the real Liss stimulator. All points will be stimulated at the same time. Patients will be seated in a comfortable chair, and the adhesive contacts of the Liss Stimulator will be placed over the acupuncture points. The treatment will consist of daily treatment for 20 minutes for two consecutive five-day intervals, followed by placement three times a week for the next two-week period. The Liss stimulator has four intensity levels. The level of intensity used will vary depending on the patient's level of comfort. The level of intensity is chosen based on the patient's feeling of tingling in the area of the contact. Once the intensity level has been set, the patient will be asked to stay seated for the 20 minutes of treatment. At the end of the treatment the contacts will be removed.
In order to measure whether the treatment has any effect on the amount of saliva a patient produces, they will be asked to give two samples of saliva twice during their treatment on day 5 and 10, and also during their one, three, and six month follow-up visits. This will require spitting into a small vial five times over a 5-minute period. The research staff will then swab a solution on the sides of the patient's tongue designed to help stimulate salivary production. The patient will then be asked to spit into another vial five times over a 5-minute period. The research staff will weigh these vials to find the amount of salivary production. The patient's salivary samples will be thrown away after the research staff have weighed them.
Patients will be asked to fill out questionnaires that will ask how the patient is feeling, how they are eating and swallowing, and how their dry mouth has changed. They will be asked to fill these out before the treatment, on days 5 and 10 of treatment, and then one, three, and six months after the treatment. These questionnaires should take 20 minutes or less to complete. As well, the research staff will ask questions about any possible side effects such as discomfort or redness at the electrostimulation site, irritation of the mouth, headache, nausea, or vomiting the patient may have.

How long will the Study run?

Patients will be in the study while they are receiving the Liss stimulator treatments and for six months after finishing the treatments.

Sponsor(s): Mayo Clinic

Study Activation/Registration Date: 02/16/2006

IRB Review and Approval Date: 12/09/2005

Study Type: Symptom Management

Projected Accrual: The plan is to have 30 patients participate at Mayo Clinic.

Costs of Study:There may be standard patient care costs related to participating in a cancer research study.

Principal Investigator: Michele Yvette Halyard, MD

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
For more information about this study or other clinical trial options, please contact our Mayo Clinic Cancer Center Clinical Trials Referral Office.

• Patients living within the United States, call 507-538-7623, or e-mail cancerclinicaltrials@mayo.edu


• Patients living outside the United States may call our International Office at 507-284-8884, or e-mail intl.mcr@mayo.edu.

What is/are the Locations of this Clinical Trial?

• Scottsdale and Phoenix, AZ

Last updated: 09/15/2009