Actively Recruiting
Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color
Led by Montefiore Medical Center · Updated on 2025-01-15
30
Participants Needed
1
Research Sites
162 weeks
Total Duration
On this page
Sponsors
M
Montefiore Medical Center
Lead Sponsor
P
Paxman
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate hairstyling techniques aimed at increasing efficacy of scalp cooling in the prevention of chemotherapy-induced alopecia, determine scalp cooling effect on persistent chemotherapy-induced alopecia, and elucidate molecular mechanisms and predictive biomarkers associated with scalp cooling success in patients with skin of color receiving chemotherapy for breast or non-small cell lung cancer. This study is being conducted because prior studies have found scalp cooling to be highly effective in preventing hair loss resulting from chemotherapy. However, minority representation was largely limited in completed trials. A recent study found that scalp cooling devices are less efficacious in patients with skin of color, likely because patients with skin of color have hair is predominantly types 3 (curly) and 4 (kinky), which tend to become bulkier when wet and can interfere with scalp cooling cap fitting. The investigators plan to test two techniques aimed at improving scalp cooling efficacy in patients with skin of color through hairstyling methods that minimize hair volume in order to increase cooling cap to scalp contact: 1) cornrows/braids/twists or 2) water/conditioner emulsion on hair. Preliminary data show that breast cancer patients with type 3 or 4 hair receiving taxane chemotherapy and scalp cooling using these techniques to prepare the hair for scalp cooling cap fitting all experienced hair preservation. Additionally, the investigators will also assess persistent chemotherapy-induced alopecia outcomes and incidence by following patients up to 6 months after completing treatment. Finally, specific gene expression changes in taxane-induced chemotherapy-induced alopecia in vitro have been described previously. The investigators will test the hypothesis that scalp cooling reverses such changes in chemotherapy-induced alopecia, assess for biomarkers predictive for scalp cooling success, and investigate persistent chemotherapy-induced alopecia molecular mechanisms using non-invasive transcriptome sequencing on plucked hair follicles.
CONDITIONS
Official Title
Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age >= 18 years
- Female
- Hair type 3 (curly) or type 4 (kinky)
- Diagnosis of breast cancer or non-small cell lung cancer or gynecologic cancer stage I-IV
- Planning to start >= 4 cycles of taxane-based chemotherapy for curative intent
- Concurrent HER, cisplatin, cyclophosphamide, and doxorubicin therapies allowed
- Eastern Cooperative Oncology Group (ECOG) status 0-2 (fully active to ambulatory and capable of self-care)
You will not qualify if you...
- Hair type other than 3 or 4
- Male
- Use of hair weave or extensions without plans to remove
- Concurrent malignancy including hematologic malignancies
- Alopecia Common Terminology Criteria for Adverse Events grade > 1 at baseline
- Past chemotherapy treatment within the last 10 years
- History of migraines or 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
- Pregnant patient
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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
CONTACT
Y
Yana Kost, BA
CONTACT
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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