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

NCT07173101

TerminatedPhase 2

Sponsor: University of Utah

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

Interventions: Semiconductor embedded headband, Sham Headband

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Salt Lake City, Utah, United States