Actively Recruiting
PREVAIL: Clinical Study Assessing Safety and Effectiveness of the Lily Device to Reduce Chemotherapy-Induced Hair Loss
Led by Luminate Medical, Inc. · Updated on 2025-01-22
85
Participants Needed
5
Research Sites
17 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 to 3. The study also aims to assess the safety of the device by monitoring any adverse events related to its use. The main questions focus on whether patients preserve their hair after four chemotherapy cycles and the occurrence of any device-related side effects. Participants will use the Lily Device during each chemotherapy session. The device must be worn during the chemotherapy infusion and for at least two hours, up to four hours, after the infusion ends. The study includes at least four cycles of chemotherapy, with various chemotherapy regimens allowed. The device's use is monitored throughout the chemotherapy treatment period. Study participants will be assessed after four chemotherapy cycles for hair preservation by both healthcare professionals and patients themselves. Researchers will collect photographs of the scalp, ask participants to complete quality of life questionnaires, and track how well participants follow the device wear schedule. Safety is closely monitored from enrollment until 30 days after the last treatment, looking for any adverse device events or serious side effects.
CONDITIONS
Brief Title
The Lily Device Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older with breast cancer stage 1, 2, or 3
- Planned intravenous chemotherapy with at least 4 cycles using specified regimens
- Head size fits within the study's device sizing range
- Plan to complete chemotherapy within 12 months
- Willing and able to provide informed consent
- Able to comply with study procedures including wearing the Lily Device and completing questionnaires
- Participants on AC-T regimens with at least 4 anthracycline and 4 taxane treatments are eligible
- Concurrent targeted agents or immunotherapy allowed at standard doses
- Participants on chemotherapy plan KEYNOTE-522 are eligible
- Prior hypersensitivity to chemotherapy allowed if standard doses maintained
You will not qualify if you...
- Baseline hair loss greater than CTCAE grade 0
- History of autoimmune hair loss diseases such as alopecia areata or systemic lupus
- History of whole brain irradiation
- Chemotherapy causing hair loss within the last 2 years
- Receiving or planning hormone replacement or anti-estrogen therapy known to cause hair loss
- Concurrent infusion of taxane-based and anthracycline-based chemotherapy on the same day
- Positive pregnancy test at baseline for those with childbearing potential
- Known allergy to any component of the Lily Device
- History of Temporomandibular Joint Disorder
- Open wounds or sores on scalp or face where device is applied
- Serious infection or medical illness that could prevent completing chemotherapy
- Life-threatening malignancy other than current breast cancer
- History or suspicion of scalp metastases
- Use of cold caps or other hair loss devices during the study
- Mental or physical inability to comply with study requirements
- Current participation in another clinical study causing hair loss or participation in this study previously
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 4 cycles of chemotherapy, each cycle lasting 14 to 21 days
Participants will wear the Lily Device at each chemotherapy session during infusion and for 2 to 4 hours post-infusion to help reduce chemotherapy-induced hair loss.
At each chemotherapy session (approximately 4 sessions)
Duration - 30 days after the last chemotherapy treatment
Participants are monitored for safety and adverse events for 30 days after the last treatment visit.
1 visit (in-person)
Trial Site Locations
Total: 5 locations
1
Inspira Health - Mullica Hills
Mullica Hill, New Jersey, United States, 08360
Actively Recruiting
2
Inspire Health - Vineland
Vineland, New Jersey, United States, 08360
Actively Recruiting
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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