Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color

Part of paid clinical trials in The Bronx, New York.

Sponsor
Montefiore Medical Center
Study ID
NCT05213936
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Scalp cooling with hairstyle — DEVICE
    Hair will be prepared accordingly for the cooling cap fitting based on which approach the patient prefers: braids/cornrows/twists
  • Scalp cooling with conditioner and water emulsion — DEVICE
    Hair will be prepared accordingly for the fitting based on which approach the patient prefers: or conditioner and water emulsion to coat the hair.

Study Details

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.

Key Dates

Start date
Oct 24, 2022
Status verified
Jan 2025
Primary completion
Jun 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Scalp cooling with hairstyle
    Scalp cooling with hairstyle (braids, twists, cornrows) to minimize hair volume and increase scalp cooling cap to scalp contact
  • Experimental: Scalp Cooling with conditioner and water emulsion
    Scalp cooling after coating hair with conditioner and water emulsion to minimize hair volume and increase scalp cooling cap to scalp contact
  • No Intervention: No Scalp Cooling
    Control with no scalp cooling

Primary Outcome Measure

Severity of chemotherapy-induced alopecia [ Time Frame: 6 months after completing treatment, up to approximately 11 months total (from the start to completion of chemotherapy) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Montefiore Medical CenterThe BronxNew York10461
Warner Robinson, DMD
[email protected]
786-385-7775

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By research site
Montefiore Medical Center· The Bronx, NY

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