RECRUITING

The Lily Device Trial

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. 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)?

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.

Quick Facts

Study Start:2024-12-20

Study Completion:2025-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06786078

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 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. 2. 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 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.	1. Baseline alopecia defined as CTCAE v5.0 grade \> 0. 2. History of autoimmune disease associated with hair loss, e.g., alopecia areata, systemic lupus. 3. History of whole brain irradiation. 4. Recent chemotherapy (≤ 2 years), which caused hair loss. 5. 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. 6. 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). 7. Positive pregnancy test at baseline for participants with childbearing potential, as per standard of care for chemotherapy patient. 8. Known or suspected allergy or hypersensitivity to any component of the Lily device that comes into contact with the study participant. 9. Participants with a history of Temporomandibular Joint Disorder. 10. 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. 11. Serious infection or medical illness which would jeopardize the ability of the participant to complete the planned chemotherapy. 12. Intercurrent life-threatening malignancy. 13. An existing history of scalp metastases or suspicion of presence of scalp metastasis. 14. Use of a cold cap, scalp cooling device or any other hair loss reduction device during the study. 15. 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. 16. Participants who do not have the mental or physical ability to comply with time schedules and further study procedures. 17. Current participation in a clinical study or within the last 30 days prior to screening that may cause hair loss. 18. Participation in this study at an earlier stage.

Inclusion Criteria

Exclusion Criteria

1. 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.
2. 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
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.

1. Baseline alopecia defined as CTCAE v5.0 grade \> 0.
2. History of autoimmune disease associated with hair loss, e.g., alopecia areata, systemic lupus.
3. History of whole brain irradiation.
4. Recent chemotherapy (≤ 2 years), which caused hair loss.
5. 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.
6. 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).
7. Positive pregnancy test at baseline for participants with childbearing potential, as per standard of care for chemotherapy patient.
8. Known or suspected allergy or hypersensitivity to any component of the Lily device that comes into contact with the study participant.
9. Participants with a history of Temporomandibular Joint Disorder.
10. 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.
11. Serious infection or medical illness which would jeopardize the ability of the participant to complete the planned chemotherapy.
12. Intercurrent life-threatening malignancy.
13. An existing history of scalp metastases or suspicion of presence of scalp metastasis.
14. Use of a cold cap, scalp cooling device or any other hair loss reduction device during the study.
15. 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.
16. Participants who do not have the mental or physical ability to comply with time schedules and further study procedures.
17. Current participation in a clinical study or within the last 30 days prior to screening that may cause hair loss.
18. Participation in this study at an earlier stage.

Contacts and Locations

Study Contact

Kimberly Wilkinson

CONTACT

+1 (713) 855-3775

kimberly.wilkinson@luminatemed.com

Study Locations (Sites)

Inspira Health - Mullica Hills

Mullica Hill, New Jersey, 08360

United States

Inspire Health - Vineland

Vineland, New Jersey, 08360

United States

Guthrie - Our Lady of Lourdes Memorial Hospital

Binghamton, New York, 13905

United States

Clinical Research Alliance

Westbury, New York, 11590

United States

Guthrie Sayer Medical Centre

Sayre, Pennsylvania, 18840

United States

Collaborators and Investigators

Sponsor: Luminate Medical, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-20

Study Completion Date2025-11

Study Record Updates

Study Start Date2024-12-20

Study Completion Date2025-11

Terms related to this study

Additional Relevant MeSH Terms

Chemotherapy Induced Alopecia