NCT06786078 · Luminate Medical, Inc.
The Lily Device Trial
(PREVAIL)
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Lily 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.
Primary outcome 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.
Time frame: 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.
Time frame: 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
- 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 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
- Head size within the specified study sizing range.
- Plan to complete chemotherapy in ≤ 12 months.
- Willing and able to sign informed consent.
- 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. To note:
- 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.
Exclusion criteria
- 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.
- Participants who are receiving or are planning to receive hormone replacement therapy or anti-estrogen therapy during the study, whereby the therapy in question has a known profile for causing hair loss.
- Prescribed chemotherapy regimen with concurrent administration of taxane-based and anthracycline-based chemotherapy (i.e., infusion of both taxane and anthracycline agents on the same day).
- Positive pregnancy test at baseline for participants with childbearing potential, as per standard of care for chemotherapy patient.
- Known or suspected allergy or hypersensitivity to any component of the Lily device that comes into contact with the study participant.
- Participants with a history of Temporomandibular Joint Disorder.
- Any open wounds or sores on the participant's scalp or on part of the face where the device will be applied, which in the opinion of the investigator will not be healed prior to chemotherapy commencing.
- Serious infection or medical illness which would jeopardize the ability of the participant to complete the planned chemotherapy.
- Intercurrent life-threatening malignancy.
- An existing history of scalp metastases or suspicion of presence of scalp metastasis.
- Use of a cold cap, scalp cooling device or any other hair loss reduction device during the study.
- Participants who, in the opinion of the investigator, will be inappropriate for inclusion into this study or will not comply with requirements of the study.
- Participants who do not have the mental or physical ability to comply with time schedules and further study procedures.
- Current participation in a clinical study or within the last 30 days prior to screening that may cause hair loss.
- Participation in this study at an earlier stage.
Where
- Mullica Hill, New Jersey
- Vineland, New Jersey
- Binghamton, New York
- Westbury, New York
- Sayre, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 22, 2025 · Source of record for eligibility and locations