Recruiting
HEADBAND

Semiconductor 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 Cancer

+ Gynecologic Cancer
+ Cancer-related Cognitive Difficulties
Over 18 Years
+18 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled
Phase 2
Interventional
Study Start: October 2025

See protocol details

Summary

Principal SponsorUniversity of Utah
Study ContactJanna Espinosa
Last updated: October 14, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: October 9, 2025Actual 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 
Principal SponsorUniversity of Utah
Study ContactJanna Espinosa
Last updated: October 14, 2025
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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive different treatments one after the other, switching from one to another during the study. This helps researchers understand how individuals respond to multiple treatments.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants, researchers, outcome assessors, and care providers do not know which treatment is being given. This is the most complete way to prevent bias and keep the study as neutral as possible.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Breast Cancer
Gynecologic Cancer
Cancer-related Cognitive Difficulties
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

Show More Criteria

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

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

To assess the safety and tolerability of semiconductor embedded headbands in the study population.

To assess the safety and tolerability of semiconductor embedded headbands in the study population.

To assess the safety and tolerability of semiconductor embedded headbands in the study population.

To assess the safety and tolerability of semiconductor embedded headbands in the study population.

To assess the safety and tolerability of semiconductor embedded headbands in the study population.

To assess the therapeutic effect of semiconductor embedded headbands to reduce cancer-related cognitive impairment (CRCI) symptoms.

To assess the effect of semiconductor embedded headbands on objective outcome measures in the study population.

To assess the effect of semiconductor embedded headbands on objective outcome measures in the study population.

To assess the effect of semiconductor embedded headbands on objective outcome measures in the study population.

To assess the effect of semiconductor embedded headbands on patient reported outcome measures in the study population.

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 UtahSalt Lake City, United StatesSee the location
Recruiting
One Study Center