NCT04805528Recruiting
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
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
Source: ClinicalTrials.gov · Last updated 11 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- First submitted
- 15 Mar 2021
- Start date
- 10 Mar 2022
- Primary completion date
- 31 May 2028
- Lead sponsor
- University of Rochester
- Diseases
- Head and neck cancer
- NCT number
- NCT04805528
What you commit to
- Study type: Interventional
- Planned participants: 75
- From 10 Mar 2022 to the primary completion date, 31 May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Inability to present for ALTENS therapy
- Ability and desire to receive concurrent chemoradiation therapy
Other illness
- 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
Age
- Age under 18 years of age
Other
- Inability to fill out quality of life questionnaires
- Pregnancy or the possibility of pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.