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

Utah System of Higher Education (USHE)

Status and phase

Enrolling

Phase 2

Conditions

Breast Cancer

Gynecologic Cancer

Cancer-related Cognitive Difficulties

Treatments

Device: Semiconductor embedded headband

Device: Sham Headband

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07173101

HCI189692

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.