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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

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
Therese Smudzin585-275-7848Therese_Smudzin@urmc.rochester.edu

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