RecruitingPhase 2NCT07173101

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

A Phase II, Double-blind, Randomized, Cross-over Clinical Investigation of the Effects of Semiconductor Embedded Therapeutic Garments on Cancer-related Cognitive Impairment in Breast and Gynecological Cancer Patients


Sponsor

University of Utah

Enrollment

50 participants

Start Date

Oct 9, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether wearing a special garment embedded with semiconductor technology can help reduce "chemo brain" — the memory, concentration, and thinking problems that many cancer survivors experience after chemotherapy — in women treated for breast or gynecologic (ovarian, uterine, cervical) cancers. **You may be eligible if...** - You are 18 or older and have been diagnosed with breast or gynecologic cancer - You recently completed chemotherapy (within the past 90 days) with no more chemotherapy planned - You are experiencing cognitive problems (e.g., trouble with memory or concentration) - You can wear the garment for at least 18 hours per day during the 6-week study - You can speak and understand English **You may NOT be eligible if...** - You have a neurodegenerative disease (e.g., Alzheimer's, Parkinson's, MS, dementia) - You had a stroke, brain injury, or meningitis in the past year - You have poorly controlled depression, schizophrenia, or bipolar disorder - You are a current tobacco or nicotine user - You have another active cancer diagnosis within the past year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESemiconductor embedded headband

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.

DEVICESham Headband

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.


Locations(1)

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, United States

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NCT07173101


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