Status:
RECRUITING
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
Lead Sponsor:
University of Rochester
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Detailed Description
In this study the investigator would like to better understand if acupuncture-like electrical therapy can be used in patients with head and neck cancer who have had radiation treatment to treat dry mo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2028
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04805528
Start Date
March 10 2022
End Date
May 31 2028
Last Update
September 11 2025
Active Locations (1)
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1
University of Rochester
Rochester, New York, United States, 14642