Using electrical stimulation to relieve dry mouth in head and neck cancer patients after radiation
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
NA · University of Rochester · NCT04805528
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Rochester (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Rochester, New York) |
| Trial ID | NCT04805528 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients currently undergoing concurrent chemoradiation therapy or those with unstable cardiac conditions may not benefit from this study.
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 performed: Previous studies have indicated that acupuncture can help alleviate dry mouth symptoms, suggesting potential success for this similar approach.
Eligibility criteria
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 this trial is running
Rochester, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Head and Neck Cancer, Acupuncture-Like Transcutaneous Electrical Stimulation, dry mouth