Semiconductor-Embedded Fabric Headbands for the Improvement of Cancer-Related Cognitive Impairment in Breast and Gynecologic Cancer Patients who have Completed Chemotherapy, HEADBAND Trial

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 Functional Assessment of Cancer Therapy (FACT)-Cognitive Function (Cog)-PCI assessment
• Ability to wear device for at least 18 hours per day during the 6 weeks of intervention
• Eastern Cooperative Oncology Group (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 central nervous system (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. Cautionary medications may be used as described