The Lily Device Trial

NCT06786078 | Recruiting FDA Device

• 1 other identifier: CLIN-1
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 5

Brief 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 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

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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.

  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.

  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.

  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.

  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.

  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

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

Study Arms (1)

Intervention

EXPERIMENTAL

Device: Lily Device

Interventions

Lily Device 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 do not have the mental or physical ability to comply with time schedules and further study procedures.

Sponsors & Collaborators

• Luminate Medical, Inc.: lead

Study Sites (5)

Inspira Health - Mullica Hills

Mullica Hill, New Jersey, 08360, United States

RECRUITING

Inspire Health - Vineland

Vineland, New Jersey, 08360, United States

RECRUITING

Guthrie - Our Lady of Lourdes Memorial Hospital

Binghamton, New York, 13905, United States

RECRUITING

Clinical Research Alliance

Westbury, New York, 11590, United States

RECRUITING

Guthrie Sayer Medical Centre

Sayre, Pennsylvania, 18840, United States

RECRUITING

Central Study Contacts

Kimberly Wilkinson

CONTACT

+1 (713) 855-3775; kimberly.wilkinson@luminatemed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 22, 2025
• Study Start: December 20, 2024
• Primary Completion: July 1, 2025
• Study Completion: November 1, 2025
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

US (5)