Clinical Investigation of the Effects of Semiconductor Embedded Therapeutic Garments on Cancer-related Cognitive Impairment in Breast and Gynecological Cancer Patients
NCT ID: NCT07173101
Last Updated: 2025-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
50 participants
INTERVENTIONAL
2025-10-09
2028-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Semiconductor embedded therapeutic headband
Semiconductor 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.
Sham Headband
Sham 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.
Interventions
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Semiconductor 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.
Sham 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.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of breast or gynecologic cancer.
* Participant has completed chemotherapy within 90 days of enrollment and no additional chemotherapy is planned for the duration of study treatment.
* Perceived cognitive impairment (PCI) score of \< 63 in the FACT-Cog-PCI assessment.
* Ability to wear device for at least 18 hours per day during the 6 weeks of intervention.
* ECOG Performance Status ≤ 3.
* Able to speak and understand English.
* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Exclusion Criteria
* History of CNS diseases such as stroke, meningitis, or traumatic brain injury within 12 months of enrollment.
* Poorly controlled psychological disorders including alcohol dependence, major depressive disorder, schizophrenia, or bipolar disorder.
* Use of tobacco or nicotine products within 90 days of enrollment.
* The diagnosis of another malignancy ≤ 12 months before study enrollment, except for those considered to be adequately treated with no evidence of disease or symptoms and/or will not require therapy during the study duration per treating investigator (i.e., basal cell or squamous cell skin cancer).
* Known brain metastases or cranial epidural disease.
* History of poorly controlled diabetes in the opinion of the investigator.
* Any other condition that would, in the Investigator's judgment, contraindicate the participant's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
* Active infection requiring systemic therapy.
* Participants taking prohibited medications as described in Section 6.5.1. Cautionary medications may be used as described in Section 6.5.2.
18 Years
ALL
No
Sponsors
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INCREDIWEAR HOLDINGS, INC.
INDUSTRY
University of Utah
OTHER
Responsible Party
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Locations
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Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HCI189692
Identifier Type: -
Identifier Source: org_study_id
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