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Acupuncture-like Electrical Therapy for Dry Mouth After Head and Neck Radiation

This study is investigating if Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS) can help treat dry mouth (xerostomia) in people who have had radiation therapy for head and neck cancer. ALTENS uses low-level electrical stimulation on acupuncture points. You may be able to join if you are over 18, have had head and neck radiation with a dose over 50 Gy, and experience dry mouth. The study will look for improvement in dry mouth symptoms using a questionnaire after 6 months. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 75 participants. It will compare symptom improvement in participants who received different radiation doses.
What's involved
You would receive ALTENS therapy twice weekly for 12 weeks. You would also need to be able and willing to attend these therapy sessions.
Compensation
Not stated in the trial record.
Follow-up
Your dry mouth symptoms will be measured at 6 months after starting the study.

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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

Recruiting
NAAges 18+InterventionalSupportive care
University of Rochester
~75 participants
Updated 2025-09-11 on ClinicalTrials.gov
What's tested:Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over 6 Months

Conditions

Head and Neck Cancer

Explore related trials

Malignant Head and Neck NeoplasmXerostomia

Where it's being run

1 sites across 1 states
New York1

Who to contact

Mary Kay Winchell
[email protected]
(585) 273-4839
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • 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 Gy6 Months

    Measure by responses to XeQoL questionnaire