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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
RECRUITINGN/ASponsored by University of Rochester
Actively Recruiting
PhaseN/A
SponsorUniversity of Rochester
Started2022-03-10
Est. completion2028-05-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT04805528
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.
Eligibility
Age: 18 Years+Healthy volunteers accepted
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
Conditions2
CancerHead and Neck Cancer
Locations1 site
University of Rochester
Rochester, New York, 14642
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Actively Recruiting
PhaseN/A
SponsorUniversity of Rochester
Started2022-03-10
Est. completion2028-05-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT04805528