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
University of Utah
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 fe…
Interventions
- DeviceSemiconductor embedded headband
Week 1-3: Participants will be provided with either an active semi-conductor headbands OR a sham headband, absent of semi-conducting fabric. Participants will be instructed to wear them \>18 hours per day and report their daily device usage. Week 4-5: Washout. Participants will not wear any headbands that were provided. Week 6-8: Participants who wore sham headbands in intervention A will be provided with active semi-conductor embedded headbands and instructed to wear them \>18 hours per day, and vice versa.
- DeviceSham Headband
Week 1-3: Participants will be provided with either an active semi-conductor headbands OR a sham headband, absent of semi-conducting fabric. Participants will be instructed to wear them \>18 hours per day and report their daily device usage. Week 4-5: Washout. Participants will not wear any headbands that were provided. Week 6-8: Participants who wore sham headbands in intervention A will be provided with active semi-conductor embedded headbands and instructed to wear them \>18 hours per day, and vice versa.
Location
- Huntsman Cancer Institute at University of UtahSalt Lake City, Utah