RECRUITING

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

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Conditions

Head and Neck CancerAcupuncture-Like Transcutaneous Electrical Stimulation (ALTENS)dry mouth

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-03-10
Study Completion:2025-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04805528

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.

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

Contacts and Locations

Study Contact

Mary Kay Winchell
CONTACT
(585) 273-4839
Marykay_Winchell@URMC.Rochester.edu
Michael Cummings
CONTACT
(585) 275-9993
Michael_Cummings@URMC.Rochester.edu

Study Locations (Sites)

University of Rochester
Rochester, New York, 14642
United States

Collaborators and Investigators

Sponsor: University of Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-10
Study Completion Date2025-05-31

Study Record Updates

Study Start Date2022-03-10
Study Completion Date2025-05-31

Terms related to this study

Keywords Provided by Researchers

  • Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS)
  • Head and Neck Cancer
  • dry mouth

Additional Relevant MeSH Terms

  • Head and Neck Cancer