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Sham Headband / Gynecologic Cancer / Semiconductor embedded headband · Phase 2 Trial
ClinicalTrials.gov · August 17, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 2 feasibility study of a semiconductor-embedded headband for cancer-related cognitive impairment that was terminated after enrolling only 7 participants. No results are reported in this registry record, and the primary endpoint—device wear adherence—does not address clinical efficacy. The study cannot be evaluated for effectiveness at this stage.
Phase 2, Interventional, Randomized, Crossover, Quadruple masking, Treatment purpose. Breast Cancer, Gynecologic Cancer, Cancer-related Cognitive Difficulties; age from 18 Years. Intervention: Semiconductor embedded therapeutic headband. Compared with: Sham Headband — Placebo Comparator. n = 7. 1 site: United States.
This is a Phase 2 feasibility study of a semiconductor-embedded headband for cancer-related cognitive impairment that was terminated after enrolling only 7 participants. No results are reported in this registry record, and the primary endpoint—device wear adherence—does not address clinical efficacy. The study cannot be evaluated for effectiveness at this stage.
No safety or effectiveness data provided. Severely underpowered sample size (n=7) precludes meaningful inference about device benefit or harm.
No clinical recommendations can be drawn from this terminated feasibility study. The primary outcome measures device adherence rather than cognitive or clinical benefit, and results are not yet available in this registry record.
This is a terminated Phase 2 feasibility study with minimal enrollment (n=7) that did not complete, assessing device wear adherence as the primary endpoint rather than clinical efficacy; no results are reported in this registry record.
As stated by the source record.
Quoted from the source exactly as published.
No clinical recommendations can be drawn from this terminated feasibility study. The primary outcome measures device adherence rather than cognitive or clinical benefit, and results are not yet available in this registry record.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07173101). This is a study registration, not published results. Lead sponsor: University of Utah. Recruitment status: TERMINATED. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 7 participants (ACTUAL). Conditions: Breast Cancer, Gynecologic Cancer, Cancer-related Cognitive Difficulties. Interventions: DEVICE: Semiconductor embedded headband; DEVICE: Sham Headband. Primary outcome measures: The primary endpoint is the proportion of patients that wear the study device for an average of at least 18 hours a day during the study period. For the device to be feasible, this proportion must be at least 75%. , 8 weeks. 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 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.