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

Description

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.

Conditions

Head and Neck Cancer

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Head and Neck Cancer
Intervention / Treatment

-

Contacts and Locations

Rochester

University of Rochester, Rochester, New York, United States, 14642

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Rochester,

Study Record Dates

2025-05-31