Actively Recruiting
Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color: A Clinical and Mechanistic Study
Led by Montefiore Medical Center · Updated on 2025-01-15
30
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
M
Montefiore Medical Center
Lead Sponsor
P
Paxman
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying ways to improve scalp cooling methods to prevent hair loss caused by chemotherapy in patients of color who have breast, non-small cell lung, or gynecologic cancers. This study focuses on patients with hair types 3 (curly) and 4 (kinky), as previous research found scalp cooling less effective for these hair types. The study also aims to understand the long-term effects of scalp cooling on persistent hair loss and to explore molecular changes and biomarkers linked to scalp cooling success using hair follicle analysis. Participants will be divided into three groups: one using scalp cooling combined with hairstyles like braids, twists, or cornrows to reduce hair volume and improve cap fit; another using scalp cooling after coating hair with a conditioner and water mixture; and a control group receiving no scalp cooling. Hair preparation methods are selected based on patient preference. The study is non-randomized and single-blinded. Throughout the study, patients will be monitored during chemotherapy and up to six months after completing treatment, for a total duration of about 11 months. Researchers will assess the severity of chemotherapy-induced hair loss and patient distress both during and after treatment. Molecular studies using non-invasive hair follicle samples will investigate gene expression changes associated with scalp cooling and persistent alopecia.
CONDITIONS
Brief Title
Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Female
- Hair type 3 (curly) or type 4 (kinky)
- Diagnosis of breast cancer, non-small cell lung cancer, or gynecologic cancer stage I-IV
- Starting at least 4 cycles of taxane-based chemotherapy for curative intent
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
You will not qualify if you...
- Hair type other than 3 or 4
- Male gender
- Use of hair weave or extensions without plans to remove
- Concurrent malignancy including hematologic cancers
- Alopecia greater than grade 1 at baseline
- Past chemotherapy within the last 10 years
- History of migraines, cluster headaches, anorexia, severe anemia, uncontrolled diabetes, hepatitis, thyroid dysfunction, cold urticaria, cold agglutinin disease, or scalp metastases
- Planned bone marrow ablation chemotherapy or skull irradiation
- Pregnancy
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 11 months from the start to completion of chemotherapy
Participants receive scalp cooling using either a hairstyle method or a conditioner and water emulsion method during chemotherapy to reduce hair loss.
Duration - 6 months after completing treatment
Participants are monitored for severity of chemotherapy-induced alopecia and patient distress for up to 6 months after completing treatment.
Trial Site Locations
Total: 1 location
1
Montefiore Medical Center
The Bronx, New York, United States, 10461
Actively Recruiting
Research Team
B
Beth McLellan, MD
Y
Yana Kost, BA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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