Clinical Investigation of the Effects of Semiconductor Embedded Therapeutic Garments on Cancer-related Cognitive Impairment in Breast and Gynecological Cancer Patients
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Utah
With
INCREDIWEAR HOLDINGS, INC.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
Clareo Health | Clinical Investigation of the Effects of Semiconductor Embedded Therapeutic Garments on Cancer-related Cognitive Impairment in Breast and Gynecological Cancer Patients
