Clinical Investigation of the Effects of Semiconductor Embedded Therapeutic Garments on Cancer-related Cognitive Impairment in Breast and Gynecological Cancer Patients

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT07173101
Phase
PHASE2
Status
Recruiting
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Conditions

  • Breast Cancer
  • Cancer-related Cognitive Difficulties
  • Gynecologic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Semiconductor embedded headband — DEVICE
    Week 1-3: Participants will be provided with either an active semi-conductor headbands OR a sham headband, absent of semi-conducting fabric. Participants will be instructed to wear them \>18 hours per day and report their daily device usage. Week 4-5: Washout. Participants will not wear any headbands that were provided. Week 6-8: Participants who wore sham headbands in intervention A will be provided with active semi-conductor embedded headbands and instructed to wear them \>18 hours per day, and vice versa.
  • Sham Headband — DEVICE
    Week 1-3: Participants will be provided with either an active semi-conductor headbands OR a sham headband, absent of semi-conducting fabric. Participants will be instructed to wear them \>18 hours per day and report their daily device usage. Week 4-5: Washout. Participants will not wear any headbands that were provided. Week 6-8: Participants who wore sham headbands in intervention A will be provided with active semi-conductor embedded headbands and instructed to wear them \>18 hours per day, and vice versa.

Study Details

The purpose of this study is to assess the feasibility of a wearing semiconductor embedded headband for cancer-related cognitive impairment in patients with breast or gynecological cancers. The study will also test the safety and effectiveness of using a semiconductor embedded headband by using a cross-over study design. The study will consist of the following phases: * Phase 1: Participants will be randomly assigned to either receive a headband with an active semiconductor or they will receive a sham headband with no semiconductor. They will wear the assigned headband for 18 hours a day for 3 weeks. * Washout Period: After the first 3-week phase, there will be a 2-week "washout" period. During this time, participants will not wear either headband to allow time for the potential treatment effects to clear from their body. * Phase 2: After the washout period, participants will switch to the other headband they were previously not receiving. They will wear this assigned headband for 18 hours a day for 3 weeks.

Key Dates

Start date
Oct 9, 2025
Status verified
Aug 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Semiconductor embedded therapeutic headband
  • Placebo Comparator: Sham Headband

Primary Outcome Measure

The primary endpoint is the proportion of patients that wear the study device for an average of at least 18 hours a day during the study period. For the device to be feasible, this proportion must be at least 75%. [ Time Frame: 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Huntsman Cancer Institute at University of UtahSalt Lake CityUtah84112
Janna Espinosa
[email protected]
801-585-0571
Mei Wei, MD
[email protected]
8015850255

Find similar trials in Salt Lake City, UT

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Huntsman Cancer Institute at University of Utah· Salt Lake City, UT

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