Status:
RECRUITING
Clinical Investigation of the Effects of Semiconductor Embedded Therapeutic Garments on Cancer-related Cognitive Impairment in Breast and Gynecological Cancer Patients
Lead Sponsor:
University of Utah
Collaborating Sponsors:
INCREDIWEAR HOLDINGS, INC.
Conditions:
Breast Cancer
Gynecologic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07173101
Start Date
October 9 2025
End Date
September 30 2028
Last Update
October 14 2025
Active Locations (1)
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1
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112