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The Lily Device Trial for Chemotherapy-Induced Hair Loss

This study is testing a device called the Lily Device to see if it can help prevent hair loss caused by chemotherapy. It also aims to understand how safe the Lily Device is. You might be able to join if you are an adult (18 or older) with breast cancer (stages 1, 2, or 3) who is about to start certain types of chemotherapy and has not yet had any other treatments. The study will look at whether your hair is preserved after 4 cycles of chemotherapy, as judged by a healthcare professional. The study is planning to enroll 85 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific intervention (the Lily Device). It plans to enroll 85 participants.
What's involved
Participants will wear the Lily Device during each chemotherapy session and for 2 to 4 hours afterward. This will continue for at least 4 cycles of chemotherapy.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored from when you join the study until a visit 30 days after your last treatment.

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NCT06786078

The Lily Device Trial

Recruiting
NAAges 18+InterventionalPrevention
Luminate Medical, Inc.
~85 participants
Updated 2025-01-22 on ClinicalTrials.gov
What's tested:Lily Device

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over After 4 cycles of chemotherapy (each cycle is 14 - 21 days dependent on the chemotherapy regimen)
+1 more outcome measured

Conditions

Chemotherapy Induced Alopecia

Explore related trials

Breast Carcinoma

Where it's being run

5 sites across 3 states
New Jersey2
New York2
Pennsylvania1

Who to contact

Kimberly Wilkinson
[email protected]
+1 (713) 855-3775
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 every 3 weeks
Concurrent administration with targeted agents/immunotherapy at standard doses (such as trastuzumab, pertuzumab, pembrolizumab) is allowed. Duration of targeted agents/immunotherapy is at the investigator's discretion.
Participants on AC-T regimens who are prescribed with at least 4 treatments with anthracycline followed by at least 4 treatments with taxane are eligible for the study. In terms of data analysis, these participants are counted towards the anthracycline group 3. Head size within the specified study sizing range. 4. Plan to complete chemotherapy in ≤ 12 months. 5. Willing and able to sign informed consent. 6. Willing to comply and tolerate all study procedures including:
Wearing the Lily device for the prescribed duration (device to be fitted before chemotherapy infusion, and worn during infusion and for at least two (2) hours and up to four (4) hours post infusion),
Complete all study related questionnaires.
Having photographs taken of the head at each visit.
Participants who experience a hypersensitivity reaction to chemotherapy are allowed to continue in the study if the standard doses are maintained.
Participants on the chemotherapy plan KEYNOTE-522 are eligible for this study.
If a participant is prescribed a different chemotherapy treatment plan, they may be eligible for the study only if prior Sponsor approval is obtained.

What this trial measures

  • 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.After 4 cycles of chemotherapy (each cycle is 14 - 21 days dependent on the chemotherapy regimen)

    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.

  • Primary Safety Endpoint - Subject incidence of Grade 1 or above ADE, graded with Common Terminology Criteria for Adverse Events (CTCAE) v5.0.From enrollment in the study until the end of study visit, taking place 30 days after the last treatment visit

    Adverse events will be graded as per the Common Terminology Criteria for Adverse Events v5.0