The Lily Device Trial
ConditionChemotherapy Induced Alopecia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLuminate Medical, Inc.
About this trial
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
Qualifiers
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.
Doxorubicin 60 mg/m² with cyclophosphamide 600 mg/m² every 2-3 weeks
Doxorubicin 60 mg/m² with fluorouracil 500 mg/m² and cyclophosphamide 500 mg/m² every 2-3 weeks
Paclitaxel 80-90 mg/m² weekly (every 3 weeks constitutes a cycle)
Disqualifiers
Baseline alopecia defined as CTCAE v5.0 grade > 0.
History of autoimmune disease associated with hair loss, e.g., alopecia areata, systemic lupus.
History of whole brain irradiation.
Recent chemotherapy (≤ 2 years), which caused hair loss.
Trial design
Treatments tested in this trial
- Lily Device
Treatment groups
85 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov