Using electrical stimulation to relieve dry mouth in head and neck cancer patients after radiation
Official 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
Run by University of Rochester · NCT04805528 · Data updated 2026-11-12
This study is testing if a new electrical therapy can help relieve dry mouth symptoms in head and neck cancer patients who have had radiation treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 75 (estimated) |
| Sponsor | University of Rochester Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Rochester, New York) |
| Status | Recruiting |
| Started | March 10, 2022 |
| Main results expected | May 31, 2028 |
| Study ends | May 31, 2028 |
| Registry record updated | September 11, 2025 |
| Trial ID | NCT04805528 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years old who have received radiation therapy for head and neck cancer and experience dry mouth symptoms.
✕Probably not a fit
Patients currently undergoing concurrent chemoradiation therapy or those with unstable cardiac conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness of acupuncture-like electrical therapy, known as ALTENS, in alleviating dry mouth symptoms in patients who have undergone radiation therapy for head and neck cancer. The approach involves applying low-level electrical stimulation to acupuncture points, which may provide similar benefits to traditional acupuncture. Participants will receive ALTENS therapy over a 12-week period, and their progress will be monitored through quality of life questionnaires. The study seeks to determine if this non-invasive method can improve the quality of life for affected patients.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from dry mouth after radiation therapy.
How similar studies have gone: Previous studies have indicated that acupuncture can help alleviate dry mouth symptoms, suggesting potential success for this similar approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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University of Rochester
Rochester, New York, United States Recruiting
Study contacts
- Study coordinator: Mary Kay Winchell
- Email: Marykay_Winchell@URMC.Rochester.edu
- Phone: (585) 273-4839
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.