PREVAIL: a Clinical Investigation on Providing Reduced Effects of Visible Alopecia Caused by Chemotherapy Using the Lily Device - a Safety and Efficacy Study.
Luminate Medical, Inc.
Summary
The goal of this clinical trial is to test if the Lily Device works to reduce chemotherapy induced hair loss in patients. It will also learn about the safety of the Lily Device. The main questions it aims to answer is: * Do patient preserve their hair using the Lily Device after 4 cycles of chemotherapy, when hair preservation is a Grade ≤1 graded by an independent healthcare professional on the Common Terminology Criteria for Adverse Events (CTCAE)? * What is the subject incidence of Grade 1 or above Adverse Device Events (ADE's)?
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Adults ≥ age 18 with breast cancer stage 1, 2 or 3, who have been deemed appropriate for (neo-)adjuvant chemotherapy and have not yet begun any systemic therapy. 2. Planned intravenous chemotherapy in the adjuvant or neoadjuvant setting with at least 4 cycles of chemotherapy, with one of the following regimens: * Doxorubicin 60 mg/m\^2 with cyclophosphamide 600 mg/m\^2 every 2-3 weeks * Doxorubicin 60 mg/m\^2 with fluorouracil 500 mg/m\^2 and cyclophosphamide 500 mg/m\^2 every 2-3 weeks * Paclitaxel 80-90 mg/m\^2 weekly (every 3 weeks constitutes a cycle) *…
Interventions
- DeviceLily Device
Participants will wear the Lily Device at each chemotherapy session for the prescribed duration, where the device must be used during infusion and for at least two (2) hours and up to four (4) hours post infusion.
Locations (5)
- Inspira Health - Mullica HillsMullica Hill, New Jersey
- Inspire Health - VinelandVineland, New Jersey
- Guthrie - Our Lady of Lourdes Memorial HospitalBinghamton, New York
- Clinical Research AllianceWestbury, New York
- Guthrie Sayer Medical CentreSayre, Pennsylvania