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

Paused · Phase 2 · Has a placebo group

Conditions studied: Breast Cancer, Gynecologic Cancer, Cancer-related Cognitive Difficulties

In brief

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.

Key facts

Study ID

NCT07173101

Run by

University of Utah

People needed

50

Starts

2025-10-09

Expected to finish

2028-09-30

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Huntsman Cancer Institute at University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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