| NCT ID | NCT06786078 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Luminate Medical, Inc. |
| Condition | Chemotherapy Induced Alopecia |
| Study Type | INTERVENTIONAL |
| Enrollment | 85 participants |
| Start Date | 2024-12-20 |
| Primary Completion | 2025-07 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 Criteria
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) * Paclitaxel 175 mg/m\^2 every 2-3 weeks * Paclitaxel 80-90 mg/m\^2 weekly (every 3 weeks constitutes a cycle) with carboplatin AUC 1.5 every week * Paclitaxel 80-90 mg/m\^2 weekly (every 3 weeks constitutes a cycle) with carboplatin AUC 5-6 every 3 weeks * Docetaxel 75-100 mg/m\^2 every 3 weeks * Docetaxel 75 mg/m\^2 with cyclophosphamide 600 mg/m\^2 every 3 weeks * Docetaxel 75 mg/m\^2 with carboplatin AUC 5-6