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: NCT04805528

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-10
• Study Completion Date: 2028-05-31

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.

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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS)

Intervention Type: RADIATION

Twice weekly ALTENS therapy for 12 weeks

Interventions

Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS)

Twice weekly ALTENS therapy for 12 weeks

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Michael Cummings

Assistant Professor - Department of Radiation Oncology (SMD)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Rochester

Rochester, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mary Kay Winchell

Role: CONTACT

Marykay_Winchell@URMC.Rochester.edu

(585) 273-4839

Michael Cummings

Role: CONTACT

Michael_Cummings@URMC.Rochester.edu

(585) 275-9993

Facility Contacts

Therese Smudzin

Role: primary

Therese_Smudzin@urmc.rochester.edu

585-275-7848

Other Identifiers

RHAN20083

Identifier Type: -

Identifier Source: org_study_id