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

June 29, 2026 updated by: University of Utah

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute At University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Semiconductor embedded therapeutic headband
Device: 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.
Placebo Comparator: Sham Headband
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The frequency of solicited adverse device effects (ADEs) and unexpected adverse device effects (UADEs) characterized by type.
Time Frame: 8 weeks
To assess the safety and tolerability of semiconductor embedded headbands in the study population.
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).
Time Frame: 8 weeks
To assess the safety and tolerability of semiconductor embedded headbands in the study population.
8 weeks
The frequency of solicited adverse device effects (ADEs) and unexpected adverse device effects (UADEs) characterized by seriousness.
Time Frame: 8 weeks
To assess the safety and tolerability of semiconductor embedded headbands in the study population.
8 weeks
The frequency of solicited adverse device effects (ADEs) and unexpected adverse device effects (UADEs) characterized by duration.
Time Frame: 8 weeks
To assess the safety and tolerability of semiconductor embedded headbands in the study population.
8 weeks
The frequency of solicited adverse device effects (ADEs) and unexpected adverse device effects (UADEs) characterized by relationship to study treatment.
Time Frame: 8 weeks
To assess the safety and tolerability of semiconductor embedded headbands in the study population.
8 weeks
Change in patient-reported cognitive function as determined by the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) compared to placebo.
Time Frame: 8 weeks
To assess the therapeutic effect of semiconductor embedded headbands to reduce cancer-related cognitive impairment (CRCI) symptoms.
8 weeks
Change in processing speed as assessed by the Trail Making Test (TMT).
Time Frame: 8 weeks
To assess the effect of semiconductor embedded headbands on objective outcome measures in the study population.
8 weeks
Change in executive function as assessed by the Stroop test.
Time Frame: 8 weeks
To assess the effect of semiconductor embedded headbands on objective outcome measures in the study population.
8 weeks
Change in verbal fluency as assessed by Controlled Oral Word Association Test (COWAT).
Time Frame: 8 weeks
To assess the effect of semiconductor embedded headbands on objective outcome measures in the study population.
8 weeks
Change in quality of life score as assessed by the EORTC Quality of Life questionnaire.
Time Frame: 8 weeks
To assess the effect of semiconductor embedded headbands on patient reported outcome measures in the study population.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

INCREDIWEAR HOLDINGS, INC.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2025

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2028

Study Registration Dates

First Submitted

September 8, 2025

First Submitted That Met QC Criteria

September 8, 2025

First Posted (Actual)

September 15, 2025

Study Record Updates

Last Update Posted (Actual)

July 1, 2026

Last Update Submitted That Met QC Criteria

June 29, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCI189692

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Semiconductor embedded headband

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe