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

NCT04805528 | Recruiting DMC

• 1 other identifier: RHAN20083
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  6 Months

Secondary Outcomes (1)

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

  6 Months

Study Arms (1)

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

EXPERIMENTAL

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.

Radiation: Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS)

Interventions

Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS) RADIATION

Twice weekly ALTENS therapy for 12 weeks

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Xerostomia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Mary Kay Winchell

CONTACT

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

Michael Cummings

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor - Department of Radiation Oncology (SMD)

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 18, 2021
• Study Start: March 10, 2022
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)