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NCT Number: NCT04805528

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester

Rochester, New York, 14642, United States

Location status: Recruiting

Location contact

Therese Smudzin

CONTACT

[email protected]

585-275-7848

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS)

Radiation

Twice weekly ALTENS therapy for 12 weeks

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

    Time frame: 6 Months

    Measure by responses to XeQoL questionnaire

Secondary outcomes

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

    Time frame: 6 Months

    Measured by adverse event severity and quantity

Study contacts

Contact information is provided by the study sponsor or research team.

Mary Kay Winchell

CONTACT

[email protected]

(585) 273-4839

Michael Cummings

CONTACT

[email protected]

(585) 275-9993

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Mar 18, 2021
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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