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
Part of paid clinical trials in Rochester, New York.
- Sponsor
- University of Rochester
- Study ID
- NCT04805528
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS) — RADIATIONTwice weekly ALTENS therapy for 12 weeks
Study Details
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.
Key Dates
- Start date
- Mar 10, 2022
- Status verified
- Sep 2025
- Primary completion
- May 31, 2028
- Completion
- May 31, 2028
Study Design
- Enrollment
- 75 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Experimental: Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS) TherapySix (6) small electrodes will be placed on specific points of the body using adhesive pads. These electrodes are connected to the ALTENS device, which will send controlled, low-level electrical impulses through the skin and into the tissue underneath.
Primary Outcome Measure
Number of patients with a mean parotid dose > 25 Gy have an improvement on the XeQoL questionnaire that is significantly different than those with a mean dose < 25 Gy [ Time Frame: 6 Months ]
Central Contacts
- Mary Kay Winchell(585) 273-4839
- Michael Cummings(585) 275-9993
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 |
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