Who is eligible for clinical trial NCT04805528?

Participants must meet protocol criteria for Head and Neck Cancer. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT04805528 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-09-09

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 (NCT04805528)

🟢 Recruiting Observational / Diagnostic 📋 Clinical Research Protocol Sponsor: University of Rochester

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (13 items).

Location: University of Rochester — Rochester, New York

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

University of Rochester — Rochester, New York

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗