Semiconductor Embedded Headband for Cancer

(HEADBAND Trial)

Overseen By Janna Espinosa

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Utah

Disqualifiers: Neurodegenerative conditions, CNS diseases, psychological disorders, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a special headband with tiny electronics, known as Semiconductor Embedded Therapeutic Garments, to address memory and thinking problems in individuals who have had breast or gynecological cancers. The goal is to determine the headband's safety and effectiveness. Participants will use both the headband and a look-alike without electronics to compare effects. The trial seeks individuals who have completed chemotherapy in the last 90 days, have noticed thinking difficulties, and can wear the headband for 18 hours a day during the study. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop taking my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants taking prohibited medications are excluded, so it's best to discuss your current medications with the study team.

What prior data suggests that the semiconductor embedded headband is safe for cancer-related cognitive impairment?

Research shows that special headbands with tiny electronic parts are being tested for their safety and effectiveness in addressing mental fog caused by cancer treatment. These headbands are under study to determine their potential to improve thinking and memory problems in patients with breast or gynecological cancers.

While detailed safety information about these headbands is not yet available, the study is in Phase 2. This indicates that earlier studies have found the headbands to be somewhat safe, but more data is needed to confirm their usability without issues. Researchers continue to monitor the headbands closely for any side effects.

For any concerns, discussing them with the trial team can provide more information about what to expect. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the semiconductor embedded therapeutic headband because it offers a new, non-invasive approach to treating cancer. Unlike traditional treatments such as chemotherapy or radiation, this headband uses embedded semiconductors to potentially target cancer cells with precise electronic signals, minimizing damage to healthy cells. This innovative delivery method could lead to fewer side effects and improve the quality of life for patients undergoing cancer treatment.

What evidence suggests that this semiconductor embedded headband is effective for cancer-related cognitive impairment?

Research has shown that headbands with tiny electronic parts might help with "chemo brain," a condition affecting memory and focus during cancer treatment. In this trial, participants may receive a semiconductor-embedded therapeutic headband, which uses gentle electrical signals to improve brain function and potentially reduce these cognitive issues. Some studies suggest that this electrical stimulation can also enhance certain immune cells' ability to fight cancer, indicating other possible benefits. Although human data remains limited, early research appears promising. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with breast or gynecological cancers experiencing cognitive impairments due to their cancer. Participants must be willing to wear a headband for long hours daily and go through two study phases with a washout period in between.

Inclusion Criteria

Able to speak and understand English

Perceived cognitive impairment (PCI) score of < 63 in the FACT-Cog-PCI assessment

Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines

Exclusion Criteria

I am currently on medication for an infection.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1

Participants are randomly assigned to receive either an active semiconductor headband or a sham headband and wear it for 18 hours a day for 3 weeks

3 weeks

Washout Period

Participants do not wear any headband to allow treatment effects to clear

2 weeks

Phase 2

Participants switch to the other headband and wear it for 18 hours a day for 3 weeks

3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Semiconductor Embedded Therapeutic Garments

Trial Overview The trial is testing the effectiveness of a semiconductor embedded headband versus a sham (inactive) headband on improving cognitive function. It involves wearing the assigned headband for several weeks, taking a break, then switching to the other type of headband.

How Is the Trial Designed?

Group I: Semiconductor embedded therapeutic headband Experimental Treatment 1 Intervention

Group II: Sham Headband Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

INCREDIWEAR HOLDINGS, INC.

Industry Sponsor

Trials

6

Recruited

630+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07173101

Study Details | NCT07173101 | Clinical Investigation of the ... The purpose of this study is to assess the feasibility of a wearing semiconductor embedded headband for cancer-related cognitive impairment in patients with ...

2. withpower.com withpower.com/trial/phase-2-neoplasms-8-2025-da7a7

Semiconductor Embedded Headband for Cancer The purpose of this study is to assess the feasibility of a wearing semiconductor embedded headband for cancer-related cognitive impairment in patients with ...

3. patlynk.com patlynk.com/trial/NCT07173101

Semiconductor Embedded Headband for Cognitive ... 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12516961/

Metal semiconductor materials in bone diseases These results indicate that electrical stimulation can enhance the antitumor capabilities of MSCs and T cells, thus suggesting a new strategy for cancer therapy ...

5. facingourrisk.org facingourrisk.org/research-clinical-trials/results?amp%3Bstudy_type=prevention_detection_risk&cancer_type=breast&page=2

Research & Clinical Trials Search Results: Breast Cancer Clinical Investigation of the Effects of Semiconductor Embedded Therapeutic Garments on Cancer-related Cognitive Impairment in Breast and Gynecological Cancer ...

6. healthcare.utah.edu healthcare.utah.edu/huntsmancancerinstitute/clinical-trials/search

Find a Clinical Trial | Huntsman Cancer Institute Evaluates the long-term safety and effectiveness of the treatment; These studies usually take place after the treatment has been approved for standard use ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10074095/

Stretchable and Skin‐Attachable Electronic Device for ... The phase‐change microcarriers embedded in the nanotextile dressing allow on‐demand anticancer drug release under electro‐thermal actuation. An ...