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NCT05213936 · ClinicalTrials.gov registry record · NA
Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color
A NA study of Alopecia, sponsored by Montefiore Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05213936: Recruiting NA study of Alopecia, sponsored by Montefiore Medical Center.
NCT05213936 is a NA study of Alopecia that is actively recruiting participants, run by Montefiore Medical Center. The registered enrollment target is 30 participants, below the 123-participant average among 13 other Alopecia trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05213936, a NA study of Alopecia, is actively recruiting participants, sponsored by Montefiore Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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-in
Primary Outcome
Severity of chemotherapy-induced alopecia, or CIA, as determined by hair count density from trichoscopy will be assessed. Hair count density (hair counts/cm\^2) will be summarized by study arm and analyzed using a T-test.
Conditions Studied
Interventions
- DEVICE Scalp cooling with hairstyle
- DEVICE Scalp cooling with conditioner and water emulsion
Study Locations (1)
New York
- Montefiore Medical Center - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-10-24 |
| Est. Completion | 2025-12 |
| Phase | NA |
What NCT05213936 shows while recruiting
NCT05213936 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 123-participant average among 13 other Alopecia trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Alopecia appearing as the primary indexed condition, and to 2 interventions - of which Scalp cooling with hairstyle is the first listed.
NCT05213936 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05213936 about?
NCT05213936 is a clinical study titled "Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color". 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 a...
What is the current status of trial NCT05213936?
This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2022-10-24. Estimated completion is 2025-12.
What conditions does trial NCT05213936 study?
This clinical trial studies the following conditions: Alopecia.
What interventions are being tested in trial NCT05213936?
The interventions under investigation include: Scalp cooling with hairstyle (DEVICE), Scalp cooling with conditioner and water emulsion (DEVICE).
Who is sponsoring clinical trial NCT05213936?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05213936 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alopecia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05213936's enrollment target sits among peer trials
30 10th of 13 higher than 3 of 13 other Alopecia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alopecia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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-
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-
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Evaluation of Scalp Cooling During Chemotherapy on Quality of Life and the Potential Role of Single Nucleotide Variations on Chemotherapy-Induced Alopecia and Hair Regrowth in the Appalachian Highlands Region
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