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

• Semiconductor embedded headband (Device): 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 Headband (Device): 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.

Primary outcomes

• 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%. [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.

Secondary outcomes

• The frequency of solicited adverse device effects (ADEs) and unexpected adverse device effects (UADEs) characterized by type. [8 weeks]: To assess the safety and tolerability of semiconductor embedded headbands in the study population.
• 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). [8 weeks]: To assess the safety and tolerability of semiconductor embedded headbands in the study population.
• The frequency of solicited adverse device effects (ADEs) and unexpected adverse device effects (UADEs) characterized by seriousness. [8 weeks]: To assess the safety and tolerability of semiconductor embedded headbands in the study population.
• The frequency of solicited adverse device effects (ADEs) and unexpected adverse device effects (UADEs) characterized by duration. [8 weeks]: To assess the safety and tolerability of semiconductor embedded headbands in the study population.
• The frequency of solicited adverse device effects (ADEs) and unexpected adverse device effects (UADEs) characterized by relationship to study treatment. [8 weeks]: To assess the safety and tolerability of semiconductor embedded headbands in the study population.
• Change in patient-reported cognitive function as determined by the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) compared to placebo. [8 weeks]: To assess the therapeutic effect of semiconductor embedded headbands to reduce cancer-related cognitive impairment (CRCI) symptoms.
• Change in processing speed as assessed by the Trail Making Test (TMT). [8 weeks]: To assess the effect of semiconductor embedded headbands on objective outcome measures in the study population.
• Change in executive function as assessed by the Stroop test. [8 weeks]: To assess the effect of semiconductor embedded headbands on objective outcome measures in the study population.
• Change in quality of life score as assessed by the EORTC Quality of Life questionnaire. [8 weeks]: To assess the effect of semiconductor embedded headbands on patient reported outcome measures in the study population.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

• Mei Wei, MD, Principal investigator, Huntsman Cancer Institute