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

Not Applicable

Recruiting

• Conditions: Head and Neck Cancer
• Interventions: Radiation: Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS)

• Registration Number: NCT04805528
• Lead Sponsor: University of Rochester

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.

Study Timeline

• Study First Submitted: 2021-03-15
• Study First Submitted QC: 2021-03-15
• Study First Posted: 2021-03-18
• Study Start: 2022-03-10
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-06
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS) Therapy	Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS)	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.

Primary Outcome Measures

Name	Time	Method
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	6 Months	Measure by responses to XeQoL questionnaire

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-Related Adverse Events [Safety and Tolerability]	6 Months	Measured by adverse event severity and quantity

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States