Clinical Trial

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

Study acronym: HEADBAND
Suspended Phase 2
View on ClinicalTrials.gov →
Why the trial stopped
Pending product compliance verification
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 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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-09-08; most recent amendment 2026-07-15.
Status change: Recruiting → Suspended 2026-06-29
Status change: Not Yet Recruiting → Recruiting 2025-10-09
Trial Details
NCT Number NCT07173101
Lead Sponsor University of Utah
Collaborators: INCREDIWEAR HOLDINGS, INC.
Conditions Breast Cancer, Gynecologic Cancer, Cancer-related Cognitive Difficulties
Enrollment 50 participants
Start Date 2025-10-09
Primary Completion 2027-09-30 (estimated)
Study Completion 2028-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-17