Chemotherapy Induced AlopeciaPREVAILNCT06786078
The Lily Device Trial
A study testing Lily Device in people with Chemotherapy Induced Alopecia, run by Luminate Medical, Inc. at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy Induced Alopecia
- What is being tested?
- Lily Device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 5 sitesUnited States
- Study dates
- 20 Dec 2024to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Guthrie - Our Lady of Lourdes Memorial Hospital
Binghamton, New York, 13905
Cynthia Campo
- Recruiting
Inspira Health - Mullica Hills
Mullica Hill, New Jersey, 08360
Jennifer Hart, 856-641-6989, hartj@ihn.org
Erev Tubb
- Recruiting
Guthrie Sayer Medical Centre
Sayre, Pennsylvania, 18840
Cathy Lanning, 570-887-4880, cathy.lanning@guthrie.org
Jennifer Schecter, FNP-C, AOCNP
- Recruiting
Inspire Health - Vineland
Vineland, New Jersey, 08360
Lynne Giglio, 856-641-6989, giglioL@ihn.org
Mylene Go
- Recruiting
Clinical Research Alliance
Westbury, New York, 11590
Rabi Khan, 516-488-2918, rkhan@researchcra.com
James T D'Olimpio
About this study
Official title: PREVAIL: a Clinical Investigation on Providing Reduced Effects of Visible Alopecia Caused by Chemotherapy Using the Lily Device - a Safety and Efficacy Study.
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)?
- Conditions
- Chemotherapy Induced Alopecia
- Being tested
- Lily Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lily DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Device: Lily Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 4 cycles of chemotherapy (each cycle is 14 - 21 days dependent on the chemotherapy regimen)
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
Measured: From enrollment in the study until the end of study visit, taking place 30 days after the last treatment visit
Secondary outcomes (12)
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%
Measured: After 4 cycles of chemotherapy
Concordance between percentage of patients with hair preservation after 4 cycles of chemotherapy as assessed by the independent healthcare professional and by the Subject.
Measured: After 4 cycles of chemotherapy (each cycle is 14 - 21 days dependent on the chemotherapy regimen)
Percentage of patients with success in hair preservation using the Lily device after 4 cycles of chemotherapy in subgroups of Subject race.
Measured: After 4 cycles of chemotherapy (each cycle is 14 - 21 days dependent on the chemotherapy regimen)
Percentage of patients with success in hair preservation using the Lily device after 4 cycles of chemotherapy in subgroups of Subject ethnicity.
Measured: After 4 cycles of chemotherapy (each cycle is 14 - 21 days dependent on the chemotherapy regimen)
Percentage of patients with success in hair preservation using the Lily device after 4 cycles of chemotherapy in subgroups of chemotherapy regimens.
Measured: After 4 cycles of chemotherapy (each cycle is 14 - 21 days dependent on the chemotherapy regimen)
Percentage of patients with success in hair preservation using the Lily device after 4 cycles of chemotherapy in subgroups of study site.
Measured: After 4 cycles of chemotherapy (each cycle is 14 - 21 days dependent on the chemotherapy regimen)
Quality of life experienced by the Subject as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) quality-of-life metrics after 4 cycles of chemotherapy.
Measured: After 4 cycles of chemotherapy (each cycle is 14 - 21 days dependent on the chemotherapy regimen)
Compliance rate, defined as the ratio of prescribed wear time versus actual wear time.
Measured: From enrollment to the end treatment at the last cycle (each cycle is 14 - 21 days dependent on the chemotherapy regimen)
Event incidence of Grade 1 or above ADE.
Measured: From study enrollment to the end of study visit, 30 days after the last treatment visit (i.e 30 days after their final chemotherapy treatment and final treatment with the Lily Device)
Subject incidence of ADEs by grade, as measured with CTCAE v5.0.
Measured: From enrollment to the end of study visit, 30 days after the last treatment visit (i.e 30 days after their final chemotherapy treatment and final treatment with the Lily Device)
Subject incidence of serious ADEs.
Measured: From enrollment to the end of study visit, 30 days after the last treatment visit (i.e 30 days after their final chemotherapy treatment and final treatment with the Lily Device).
Adverse events of special interest (AESIs) incidence relating to scalp metastasis.
Measured: From enrollment to the end of study visit, 30 days after the last treatment visit (i.e 30 days after their final chemotherapy treatment and final treatment with the Lily Device).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start20 Dec 2024
- Primary completionJul 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy Induced AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luminate Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786078
- Sponsor's protocol ID
- CLIN-1
- Acronym
- PREVAIL
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2025
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREVAIL: a Clinical Investigation on Providing Reduced Effects of Visible Alopecia Caused by Chemotherapy Using the Lily Device - a Safety and Efficacy Study.
- ClinicalTrials.gov ID
- NCT06786078
- Acronym / sponsor ID
- PREVAIL / CLIN-1
- Conditions
- Chemotherapy Induced Alopecia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Luminate Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)?
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Lily Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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:
- Head size within the specified study sizing range.
- Plan to complete chemotherapy in ≤ 12 months.
- Willing and able to sign informed consent.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lily 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. | Device | Intervention |
Primary outcome
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
12 secondary outcomes
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.
Time frame: After 4 cycles of chemotherapy
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)
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)
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)
Percentage of patients with success in hair preservation using the Lily device after 4 cycles of chemotherapy in subgroups of chemotherapy regimens.
Time frame: After 4 cycles of chemotherapy (each cycle is 14 - 21 days dependent on the chemotherapy regimen)
Percentage of patients with success in hair preservation using the Lily device after 4 cycles of chemotherapy in subgroups of study site.
Time frame: After 4 cycles of chemotherapy (each cycle is 14 - 21 days dependent on the chemotherapy regimen)
Quality of life experienced by the Subject as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) quality-of-life metrics after 4 cycles of chemotherapy.
Time frame: After 4 cycles of chemotherapy (each cycle is 14 - 21 days dependent on the chemotherapy regimen)
Compliance rate, defined as the ratio of prescribed wear time versus actual wear time.
Time frame: From enrollment to the end treatment at the last cycle (each cycle is 14 - 21 days dependent on the chemotherapy regimen)
Event incidence of Grade 1 or above ADE.
Time frame: From study enrollment to the end of study visit, 30 days after the last treatment visit (i.e 30 days after their final chemotherapy treatment and final treatment with the Lily Device)
Subject incidence of ADEs by grade, as measured with CTCAE v5.0.
Time frame: From enrollment to the end of study visit, 30 days after the last treatment visit (i.e 30 days after their final chemotherapy treatment and final treatment with the Lily Device)
Subject incidence of serious ADEs.
Time frame: From enrollment to the end of study visit, 30 days after the last treatment visit (i.e 30 days after their final chemotherapy treatment and final treatment with the Lily Device).
Adverse events of special interest (AESIs) incidence relating to scalp metastasis.
Time frame: From enrollment to the end of study visit, 30 days after the last treatment visit (i.e 30 days after their final chemotherapy treatment and final treatment with the Lily Device).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lily Device in people with Chemotherapy Induced Alopecia, run by Luminate Medical, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kimberly Wilkinson (+1 (713) 855-3775, kimberly.wilkinson@luminatemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.