Semiconductor headband for chemo-related thinking problems in breast and gynecologic cancer patients
A Phase II, Double-blind, Randomized, Cross-over Clinical Investigation of the Effects of Semiconductor Embedded Therapeutic Garments on Cancer-related Cognitive Impairment in Breast and Gynecological Cancer Patients
This study will test whether wearing a semiconductor-embedded headband can help people with breast or gynecologic cancer who have cognitive problems after chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Utah Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Salt Lake City, Utah) |
| Trial ID | NCT07173101 on ClinicalTrials.gov |
What this trial studies
This randomized, phase 2 crossover trial compares an active semiconductor-embedded headband with a sham headband in patients with breast or gynecologic cancer who report cognitive impairment after chemotherapy. Participants are randomly assigned to wear either the active or sham headband for 18 hours per day for three weeks, then have a two-week washout before switching to the other device for another three weeks. The trial measures feasibility, safety, and signals of effectiveness using patient-reported cognitive scores and clinical assessments. The crossover design lets each participant serve as their own control to improve comparison between active and sham periods.
Who should consider this trial
Good fit: Adults with breast or gynecologic cancer who finished chemotherapy within the prior 90 days, report cognitive complaints (FACT-Cog PCI score <63), can wear the device at least 18 hours per day, and meet other medical and language criteria are the intended participants.
Not a fit: People with neurodegenerative disease, recent major CNS events, poorly controlled psychiatric conditions, those still receiving chemotherapy, or those unable to wear the device as required are unlikely to benefit from this study intervention.
Why it matters
Potential benefit: If effective, the headband could reduce cognitive symptoms and improve daily thinking, memory, and functioning for people recovering from chemotherapy.
How similar studies have performed: This wearable semiconductor approach is largely novel for cancer-related cognitive problems, with only limited and preliminary evidence from related wearable neuromodulation approaches.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Salt Lake City, Utah
- Huntsman Cancer Institute at University of Utah — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Janna Espinosa
- Email: janna.espinosa@hci.utah.edu
- Phone: 8015850571
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.