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RECRUITING
NCT05213936
NA

Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color

Sponsor: Montefiore Medical Center

View on ClinicalTrials.gov

Summary

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.

Official title: Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color: A Clinical and Mechanistic Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2022-10-24

Completion Date

2025-12

Last Updated

2025-01-15

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Scalp cooling with hairstyle

Hair will be prepared accordingly for the cooling cap fitting based on which approach the patient prefers: braids/cornrows/twists

DEVICE

Scalp cooling with conditioner and water emulsion

Hair will be prepared accordingly for the fitting based on which approach the patient prefers: or conditioner and water emulsion to coat the hair.

Locations (1)

Montefiore Medical Center

The Bronx, New York, United States