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

NCT07173101 | Recruiting Phase 2 DMC

• 1 other identifier: HCI189692
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Gynecologic Cancer; Cancer-related Cognitive Difficulties

Outcome Measures

Primary Outcomes (1)

• 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%.

  The primary objective is to assess the feasibility of wearing semiconductor embedded headbands for cancer-related cognitive impairment in breast and gynecological patients.

  8 weeks

Secondary Outcomes (10)

• The frequency of solicited adverse device effects (ADEs) and unexpected adverse device effects (UADEs) characterized by type.

  8 weeks

• The frequency of solicited adverse device effects (ADEs) and unexpected adverse device effects (UADEs) characterized by severity (as defined by the NIH CTCAE, version 5.0).

  8 weeks

• The frequency of solicited adverse device effects (ADEs) and unexpected adverse device effects (UADEs) characterized by seriousness.

  8 weeks

• The frequency of solicited adverse device effects (ADEs) and unexpected adverse device effects (UADEs) characterized by duration.

  8 weeks

• The frequency of solicited adverse device effects (ADEs) and unexpected adverse device effects (UADEs) characterized by relationship to study treatment.

  8 weeks

Study Arms (2)

Semiconductor embedded therapeutic headband

EXPERIMENTAL

Device: Semiconductor embedded headband

Sham Headband

PLACEBO COMPARATOR

Device: Sham Headband

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.

Semiconductor embedded therapeutic headband

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.

Sham Headband

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant aged 18 years or older.
• 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.

You may not qualify if:

• History of neurodegenerative conditions, including but not limited to multiple sclerosis, dementia, Alzheimer's, or Parkinson's disease.
• 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.

Sponsors & Collaborators

• University of Utah: lead
• INCREDIWEAR HOLDINGS, INC.: collaborator

Study Sites (1)

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Janna Espinosa

CONTACT

8015850571; janna.espinosa@hci.utah.edu

Mei Wei, MD

CONTACT

801-585-0255; Mei.Wei@hci.utah.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study will blind the participant, the investigator, and the study team to the treatment assignment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 15, 2025
• Study Start: October 9, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: October 14, 2025

Record last verified: 2025-08

Locations

US (1)