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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
Hair will be prepared accordingly for the cooling cap fitting based on which approach the patient prefers: braids/cornrows/twists
Hair will be prepared accordingly for the fitting based on which approach the patient prefers: or conditioner and water emulsion to coat the hair.
Montefiore Medical Center
The Bronx, New York, United States
RECRUITINGSeverity of chemotherapy-induced alopecia
The severity of chemotherapy-induced alopecia as determined by hair counts with trichoscopy with measurements of hair shaft diameter \& follicle density and Common Terminology Criteria for Adverse Events (CTCAE Version 5.0) grading
Time frame: 6 months after completing treatment, up to approximately 11 months total (from the start to completion of chemotherapy)
Patient distress during treatment
Assessed by the Chemotherapy Alopecia Distress Scale and patient self-assessment of hair growth using Common Terminology Criteria for Adverse Events
Time frame: 6 months after completing treatment, up to approximately 11 months (from the start to completion of chemotherapy)
Severity of persistent chemotherapy-induced alopecia
The severity of chemotherapy-induced alopecia as determined by hair counts with trichoscopy with measurements of hair shaft diameter \& follicle density and Common Terminology Criteria for Adverse Events (CTCAE Version 5.0) grading
Time frame: 26 weeks (starting after chemotherapy completion)
Patient distress after treatment
Assessed by the Chemotherapy Alopecia Distress Scale and patient self-assessment of hair growth using Common Terminology Criteria for Adverse Events 26 weeks after chemotherapy completion
Time frame: 26 weeks (starting after chemotherapy completion)
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