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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

NCT ID: NCT04805528Sponsor: University of RochesterLast updated: 2025-09-11

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.

Arms & interventions

  • RadiationAcupuncture-Like Transcutaneous Electrical Stimulation (ALTENS)

    Twice weekly ALTENS therapy for 12 weeks

Outcome measures

Primary

  • 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

    Measure by responses to XeQoL questionnaire

    Time frame: 6 Months

Secondary

  • Incidence of Treatment-Related Adverse Events [Safety and Tolerability]

    Time frame: 6 Months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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

Study locations (1)

University of Rochester

Rochester, New York, 14642

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 | Cancerify