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 now · Not applicable

Conditions studied: Head and Neck Cancer

In brief

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.

Key facts

Study ID

NCT04805528

Run by

University of Rochester

People needed

75

Starts

2022-03-10

Expected to finish

2028-05-31

Last updated by the study team

2025-09-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• University of Rochester — Rochester, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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