Recruiting

HEADBANDSemiconductor Embedded Headband for Cognitive Impairment in Breast and Gynecological Cancer

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What is being tested

Semiconductor embedded headband

+ Sham Headband

Device
Who is being recruted

Breast Diseases+3

+ Breast Neoplasms

+ Neoplasms

Over 18 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: October 2025
See protocol details

Summary

Principal SponsorUniversity of Utah
Study ContactMei Wei, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 9, 2025

Actual date on which the first participant was enrolled.

This study is exploring a new way to help people with breast or gynecological cancers who experience cognitive difficulties, often referred to as "chemo brain." The focus is on a special headband that contains tiny semiconductor devices which may help improve these cognitive challenges. By testing this headband, the study aims to see if it is a safe and effective tool for easing the mental fog that can accompany cancer treatment. This research could potentially offer a non-invasive option to improve quality of life for those affected by cognitive impairment related to cancer. Participants in the study will take part in two main phases. Initially, they will be randomly given either an active headband with the semiconductor or a lookalike headband without the active component, wearing it for 18 hours each day over three weeks. After this first phase, there is a two-week break called a "washout period" where no headbands are worn. This helps clear any effects from the initial headband. Following this break, participants switch headbands, wearing the opposite headband for another three weeks. This design helps researchers compare the effects of the real headband against the sham version to determine its true effectiveness and safety.

Official TitleA 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
NCT07173101
Principal SponsorUniversity of Utah
Study ContactMei Wei, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Criteria

8 inclusion criteria required to participate
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.
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10 exclusion criteria prevent from participating
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.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Huntsman Cancer Institute at University of Utah

Salt Lake City, United StatesOpen Huntsman Cancer Institute at University of Utah in Google Maps
Recruiting
One Study Center