HEADBANDSemiconductor Embedded Headband for Cognitive Impairment in Breast and Gynecological Cancer
Semiconductor embedded headband
+ Sham Headband
Breast Diseases+3
+ Breast Neoplasms
+ Neoplasms
Treatment Study
Summary
Study start date: October 9, 2025
Actual date on which the first participant was enrolled.This study is exploring a new way to help people with breast or gynecological cancers who experience cognitive difficulties, often referred to as "chemo brain." The focus is on a special headband that contains tiny semiconductor devices which may help improve these cognitive challenges. By testing this headband, the study aims to see if it is a safe and effective tool for easing the mental fog that can accompany cancer treatment. This research could potentially offer a non-invasive option to improve quality of life for those affected by cognitive impairment related to cancer. Participants in the study will take part in two main phases. Initially, they will be randomly given either an active headband with the semiconductor or a lookalike headband without the active component, wearing it for 18 hours each day over three weeks. After this first phase, there is a two-week break called a "washout period" where no headbands are worn. This helps clear any effects from the initial headband. Following this break, participants switch headbands, wearing the opposite headband for another three weeks. This design helps researchers compare the effects of the real headband against the sham version to determine its true effectiveness and safety.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location