Recruiting

Acupuncture-like Electrical Therapy

Sponsor:

University of Rochester

Code:

NCT04805528

Conditions

Head and Neck Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS)

Study Details

Brief 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.

Conditions

Head and Neck Cancer

Study ID

NCT04805528

Start date

Mar 10, 2022

Status verified date

Sep, 2025

Completion date

May 31, 2028

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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

Study Design

Enrollment

75 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Experimental: Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS) Therapy

Six (6) small electrodes will be placed on specific points of the body using adhesive pads. These electrodes are connected to the ALTENS device, which will send controlled, low-level electrical impulses through the skin and into the tissue underneath.

Interventions

Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS)

Twice weekly ALTENS therapy for 12 weeks

Primary outcome measure

  • 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 [ Time Frame: 6 Months ]

Central Contacts and Locations

Central contacts

Mary Kay Winchell

(585) 273-4839Marykay_Winchell@URMC.Rochester.edu

Michael Cummings

(585) 275-9993Michael_Cummings@URMC.Rochester.edu

Locations

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Therese Smudzin

585-275-7848Therese_Smudzin@urmc.rochester.edu

More Information

Sponsor

University of Rochester

Last update posted

Sep 11, 2025

Last verified

Sep, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2025-09-11.