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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Lily Device
DeviceParticipants 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.
Treatment groups
85 Participants
are divided into 1 treatment groupGroup A: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Success in hair preservation using the Lily device after 4 cycles of chemotherapy, where hair preservation is defined as CTCAE v5.0 grade ≤ 1 alopecia determined by an independent healthcare professional.
A cycle of chemotherapy relates to the delivery of the chemotherapy regimen. In particular: * Participants on regimens delivered every 3 weeks - 1 chemotherapy treatment = 1 cycle. * Participants on regimens delivered every 2 weeks - 1 chemotherapy treatment = 1 cycle. * Participants on regimens delivered every 1 week - 3 chemotherapy treatments = 1 cycle. In CTCAE v5.0 alopecia grades are described as below: * Grade 0: No hair loss * Grade 1: Hair loss of \<50% of normal for that individual that is not obvious from a distance but only on close inspection; a different hair style may be required to cover the hair loss, but it does not require a wig or hair piece to camouflage. * Grade 2: Hair loss of ≥50% normal for that individual that is readily apparent to others; a wig or hair piece is necessary if the patient desires to completely camouflage the hair loss; associated with psychosocial impact.
Time frame
After 4 cycles of chemotherapy (each cycle is 14 - 21 days dependent on the chemotherapy regimen)2
Primary Safety Endpoint - Subject incidence of Grade 1 or above ADE, graded with Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Adverse events will be graded as per the Common Terminology Criteria for Adverse Events v5.0
Time frame
From enrollment in the study until the end of study visit, taking place 30 days after the last treatment visitSecondary outcomes
1
Hair preservation experienced with the Lily device after 4 cycles of chemotherapy (each cycle is 14 - 21 days dependent on the chemotherapy regimen)as assessed by the Subject according to the Dean Scale, with Grade 0, 1 or 2 defined as success.
A cycle of chemotherapy relates to the delivery of the chemotherapy regimen. In particular: - Participants on regimens delivered every 3 weeks - 1 chemotherapy treatment = 1 cycle. - Participants on regimens delivered every 2 weeks - 1 chemotherapy treatment = 1 cycle. - Participants on regimens delivered every 1 week - 3 chemotherapy treatments = 1 cycle. In the Dean Scale alopecia grades are described as below: * Grade 0: No hair loss * Grade 1: Hair loss of \<25% * Grade 2: Hair loss of 25% ≤ hair loss \< 50% * Grade 3: 50% ≤ hair loss \< 75% * Grade 4: hair loss ≥ 75%
Time frame
After 4 cycles of chemotherapy2
Concordance between percentage of patients with hair preservation after 4 cycles of chemotherapy as assessed by the independent healthcare professional and by the Subject.
Time frame
After 4 cycles of chemotherapy (each cycle is 14 - 21 days dependent on the chemotherapy regimen)3
Percentage of patients with success in hair preservation using the Lily device after 4 cycles of chemotherapy in subgroups of Subject race.
Time frame
After 4 cycles of chemotherapy (each cycle is 14 - 21 days dependent on the chemotherapy regimen)4
Percentage of patients with success in hair preservation using the Lily device after 4 cycles of chemotherapy in subgroups of Subject ethnicity.
Time frame
After 4 cycles of chemotherapy (each cycle is 14 - 21 days dependent on the chemotherapy regimen)Other outcomes
1
Percentage of patients with hair preservation by hair type, based on standardized photographs acquired as part of the primary endpoint
Time frame
After 4 cycles of chemotherapy (each cycle is 14 - 21 days dependent on the chemotherapy regimen)Sponsors and contacts
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Source ClinicalTrials.gov