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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Head and Neck Cancer
- Sponsor
- University of Rochester
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
Brief Summary
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
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.
Investigators
Michael Cummings
Assistant Professor - Department of Radiation Oncology (SMD)
University of Rochester
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
Time Frame: 6 Months
Measure by responses to XeQoL questionnaire
Secondary Outcomes
- Incidence of Treatment-Related Adverse Events [Safety and Tolerability](6 Months)