Breast CancerPhase 2HEADBANDNCT07173101
Clinical Investigation of the Effects of Semiconductor Embedded Therapeutic Garments on Cancer-related Cognitive Impairment in Breast and Gynecological Cancer Patients
A Phase 2 study testing Semiconductor embedded headband in people with Breast Cancer and Gynecologic Cancer, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Gynecologic Cancer, Cancer-related Cognitive Difficulties
- What is being tested?
- Semiconductor embedded headband
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2025to 3 Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, 84112
About this study
Official title: 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.
- Being tested
- Semiconductor embedded headband, Sham Headband
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semiconductor embedded headbandDevice
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 HeadbandDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Semiconductor embedded therapeutic headband | Experimental | Not described Receives: Device: Semiconductor embedded headband |
| Sham Headband | Placebo comparator | Not described Receives: Device: Sham Headband |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (9)
The frequency of solicited adverse device effects (ADEs) and unexpected adverse device effects (UADEs) characterized by type.
To assess the safety and tolerability of semiconductor embedded headbands in the study population.
Measured: 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).
To assess the safety and tolerability of semiconductor embedded headbands in the study population.
Measured: 8 weeks
The frequency of solicited adverse device effects (ADEs) and unexpected adverse device effects (UADEs) characterized by seriousness.
To assess the safety and tolerability of semiconductor embedded headbands in the study population.
Measured: 8 weeks
The frequency of solicited adverse device effects (ADEs) and unexpected adverse device effects (UADEs) characterized by duration.
To assess the safety and tolerability of semiconductor embedded headbands in the study population.
Measured: 8 weeks
The frequency of solicited adverse device effects (ADEs) and unexpected adverse device effects (UADEs) characterized by relationship to study treatment.
To assess the safety and tolerability of semiconductor embedded headbands in the study population.
Measured: 8 weeks
Change in patient-reported cognitive function as determined by the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) compared to placebo.
To assess the therapeutic effect of semiconductor embedded headbands to reduce cancer-related cognitive impairment (CRCI) symptoms.
Measured: 8 weeks
Change in processing speed as assessed by the Trail Making Test (TMT).
To assess the effect of semiconductor embedded headbands on objective outcome measures in the study population.
Measured: 8 weeks
Change in executive function as assessed by the Stroop test.
To assess the effect of semiconductor embedded headbands on objective outcome measures in the study population.
Measured: 8 weeks
Change in quality of life score as assessed by the EORTC Quality of Life questionnaire.
To assess the effect of semiconductor embedded headbands on patient reported outcome measures in the study population.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start7 Nov 2025
- Primary completion3 Jul 2026
- Study completion3 Jul 2026
Why it stopped: Safety Review
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- INCREDIWEAR HOLDINGS, INC.
- Responsible party
- Sponsor
- Investigators
- Mei Wei, MD, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173101
- Sponsor's protocol ID
- HCI189692
- Acronym
- HEADBAND
- Status last verified
- Jul 2026
- First submitted
- 8 Sep 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07173101
- Acronym / sponsor ID
- HEADBAND / HCI189692
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Safety Review
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- INCREDIWEAR HOLDINGS, INC.
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- 3 Jul 2026 (actual)
- Study completion
- 3 Jul 2026 (actual)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semiconductor embedded therapeutic headband | Experimental | Device: Semiconductor embedded headband |
| Sham Headband | Placebo comparator | Device: Sham Headband |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semiconductor embedded headbandWeek 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. | Device | Semiconductor embedded therapeutic headband |
| Sham HeadbandWeek 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. | Device | Sham Headband |
Primary outcome
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.
9 secondary outcomes
The frequency of solicited adverse device effects (ADEs) and unexpected adverse device effects (UADEs) characterized by type.
Time frame: 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
The frequency of solicited adverse device effects (ADEs) and unexpected adverse device effects (UADEs) characterized by seriousness.
Time frame: 8 weeks
The frequency of solicited adverse device effects (ADEs) and unexpected adverse device effects (UADEs) characterized by duration.
Time frame: 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
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
Change in processing speed as assessed by the Trail Making Test (TMT).
Time frame: 8 weeks
Change in executive function as assessed by the Stroop test.
Time frame: 8 weeks
Change in quality of life score as assessed by the EORTC Quality of Life questionnaire.
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: Safety Review). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mei Wei, MD principal investigator
Huntsman Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Semiconductor embedded headband in people with Breast Cancer and Gynecologic Cancer, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Safety Review). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.