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) — RADIATION
    Twice 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) Therapy
    Six (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

Locations (1)

FacilityCityStateZIPSite coordinators
University of RochesterRochesterNew York14642
Therese Smudzin
585-275-7848

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