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PREVAIL Study on Using the Lily Device to Reduce Hair Loss Caused by Chemotherapy in Breast Cancer Patients A Safety and Efficacy Clinical Trial
Led by Luminate Medical, Inc. · Updated on 2025-01-22
85
Participants Needed
5
Research Sites
45 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Lily Device to see if it can reduce hair loss caused by chemotherapy in adults with breast cancer stages 1, 2, or 3. The study focuses on whether patients can preserve their hair after four chemotherapy cycles and also aims to assess the safety of the Lily Device by monitoring any adverse device events. The device use is being studied in the context of specific chemotherapy regimens over a treatment period lasting up to 12 months. Participants will wear the Lily Device during each chemotherapy session, starting before infusion and continuing for at least two hours and up to four hours after infusion. The chemotherapy treatments include various regimens such as doxorubicin, paclitaxel, and docetaxel combinations, with some participants also receiving targeted therapies concurrently. The study requires participants to complete at least four cycles of chemotherapy while using the device. During the study, participants will be monitored for hair preservation by an independent healthcare professional using a standard grading scale after four chemotherapy cycles. Safety will be tracked by recording any adverse events related to the device from enrollment until 30 days after the last treatment. Participants will also complete questionnaires and have photographs of their scalp taken at each visit to document hair condition and device use. Overall participation may last up to 12 months, including follow-up assessments.
CONDITIONS
Official Title
The Lily Device Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older with stage 1, 2, or 3 breast cancer who have not started systemic therapy
- Planned intravenous chemotherapy with at least 4 cycles using specified regimens including doxorubicin, paclitaxel, or docetaxel
- Head size within the study's specified sizing range
- Plan to complete chemotherapy within 12 months
- Willing and able to sign informed consent
- Willing to comply with study procedures including wearing the Lily Device during and after chemotherapy infusion, completing questionnaires, and having scalp photographs taken
You will not qualify if you...
- Baseline hair loss greater than grade 0 on the CTCAE v5.0 scale
- History of autoimmune diseases causing hair loss such as alopecia areata or systemic lupus
- History of whole brain radiation
- Chemotherapy within the past 2 years that caused hair loss
- Receiving or planning to receive hormone replacement or anti-estrogen therapy known to cause hair loss during the study
- Chemotherapy regimen including taxane and anthracycline agents administered on the same day
- Positive pregnancy test at baseline for participants able to bear children
- Known allergy or sensitivity to any part of the Lily Device
- History of Temporomandibular Joint Disorder
- Open wounds or sores on scalp or face where device will be applied
- Serious infections or medical conditions that prevent completing chemotherapy
- Life-threatening cancers other than the current breast cancer
- Existing or suspected scalp metastases
- Use of other hair loss prevention devices during the study
- Participation in other clinical studies causing hair loss within 30 days before screening
- Previous participation in this study
- Inability to comply with study schedules or procedures due to mental or physical reasons
- Investigator judgement that participant is inappropriate for the study or will not comply
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Inspira Health - Mullica Hills
Mullica Hill, New Jersey, United States, 08360
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2
Inspire Health - Vineland
Vineland, New Jersey, United States, 08360
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3
Guthrie - Our Lady of Lourdes Memorial Hospital
Binghamton, New York, United States, 13905
Actively Recruiting
4
Clinical Research Alliance
Westbury, New York, United States, 11590
Actively Recruiting
5
Guthrie Sayer Medical Centre
Sayre, Pennsylvania, United States, 18840
Actively Recruiting
Research Team
K
Kimberly Wilkinson
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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