Study of Non-invasive Acupuncture-like Transcutaneous Electrical Nerve Stimulation (Altens) to Help Alleviate Xerostomia After Radiation Therapy for Cancers of the Head and Neck

Study Overview
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Brief Summary
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The purpose of this study would like to learn if acupuncture-like electrical therapy can be used in patients with head and neck cancer who have had radiation treatment to treat dry mouth.

Detailed Description
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In this study the investigator would like to better understand if acupuncture-like electrical therapy can be used in patients with head and neck cancer who have had radiation treatment to treat dry mouth. Acupuncture has been shown to help some people with symptoms of dry mouth, and low-level electrical stimulation of acupuncture points has been shown to have similar results as acupuncture treatment with needles.

Official Title
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Prospective Study of Non-invasive Acupuncture-like Transcutaneous Electrical Nerve Stimulation (Altens) to Help Alleviate Xerostomia After Radiation Therapy for Cancers of the Head and Neck

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Radiation: Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years No restrictions on gender or ethnicity Ability and willingness to present for ALTENS therapy over 12 weeks Previous radiation to the head and neck with a dose > 50 Gy Subjective complaint of dry mouth No evidence of active malignancy in the head and neck region Minimum of 3 months post initial curative therapy with no evidence of active disease by standard of care surveillance scans for said disease site Exclusion Criteria: Age under 18 years of age Inability to present for ALTENS therapy Inability to fill out quality of life questionnaires Ability and desire to receive concurrent chemoradiation therapy Because ALTENs may stimulate nerves similar to those of pilocarpine, the following exclusions are noted as theoretically ALTENS could produce worse symptoms Unstable Angina Unstable cardiac disease with hospitalization in the last 6 months Presence of a pacemaker, ICD, or other electronic implanted device that could be affected Myocardial infarction in the last 6 months Symptomatic arrhythmia in the last 6 months Severe COPD with exacerbation causing hospitalization within the last 6 months Pregnancy or the possibility of pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS) Therapy<br>Six (6) small electrodes will be placed on specific points of the body using adhesive pads. These electrodes are connected to the ALTENS device, which will send controlled, low-level electrical impulses through the skin and into the tissue underneath. | Radiation: Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS)<br>* Twice weekly ALTENS therapy for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with a mean parotid dose > 25 Gy have an improvement on the XeQoL questionnaire that is significantly different than those with a mean dose < 25 Gy | Measure by responses to XeQoL questionnaire | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Related Adverse Events [Safety and Tolerability] | Measured by adverse event severity and quantity | 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head and Neck Cancer, dry mouth, Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS)