Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color

July 14, 2026 updated by: Montefiore Medical Center

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • The Bronx, New York, United States, 10461
        • Recruiting
        • Montefiore Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age >= 18 years
  2. Female
  3. Hair type 3 (curly) or type 4 (kinky)
  4. Diagnosis of breast cancer or non-small cell lung cancer (NSCLC) or gynecologic cancer stage I-IV

  5. Patient will be starting >= 4 cycles of taxane-based chemotherapy treatment for curative intent after enrollment

    a. Concurrent HER, cisplatin, cyclophosphamide therapies and doxorubicin therapies allowed

  6. Eastern Cooperative Oncology Group (ECOG) 0-2: fully active, restrictive in physically strenuous activity, ambulatory and capable of self-care

Exclusion Criteria:

  1. Hair type other than 3 or 4
  2. Male
  3. Use of hair weave or extensions without plans to remove
  4. Concurrent malignancy including hematologic malignancies (i.e. leukemia or lymphoma)
  5. Alopecia Common Terminology Criteria for Adverse Events > grade 1 at baseline
  6. Past chemotherapy administration if past treatment was <= 10 years ago
  7. History of migraines or cluster headaches, anorexia, severe anemia, uncontrolled diabetes, hepatitis, thyroid dysfunction, cold urticaria, cold agglutinin disease, scalp metastases
  8. Planned bone marrow ablation chemotherapy or skull irradiation
  9. Pregnant patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Scalp cooling with hairstyle
Scalp cooling with hairstyle (braids, twists, cornrows) to minimize hair volume and increase scalp cooling cap to scalp contact
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
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
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.
No Intervention: No Scalp Cooling
Control with no scalp cooling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of chemotherapy-induced alopecia - hair count density
Time Frame: 4 weeks after completion of chemotherapy, up to ~6 months total
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.
4 weeks after completion of chemotherapy, up to ~6 months total
Severity of chemotherapy-induced alopecia - adverse events
Time Frame: 4 weeks after the completion of chemotherapy, up to ~6 months total
Severity of CIA will also be evaluated based on Common Terminology Criteria for Adverse Events (CTCAE Version 5.0) grading. Results will be summarized by study arm and analyzed Fisher's exact test.
4 weeks after the completion of chemotherapy, up to ~6 months total

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of persistent chemotherapy-induced alopecia (PCIA) - hair count density
Time Frame: 26 weeks after completion of chemotherapy, up to ~11 months total
Severity of PCIA, 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.
26 weeks after completion of chemotherapy, up to ~11 months total
Severity of persistent chemotherapy-induced alopecia - adverse events
Time Frame: 26 weeks after completion of chemotherapy, up to ~11 months total
Severity of PCIA will also be evaluated based on Common Terminology Criteria for Adverse Events (CTCAE Version 5.0) grading. Results will be summarized by study arm and analyzed Fisher's exact test.
26 weeks after completion of chemotherapy, up to ~11 months total
Patient distress after treatment
Time Frame: 4 weeks, 8 weeks, 12 weeks, and 26 weeks after completion of chemotherapy, up to ~11 months total (from the start to completion of chemotherapy)
Patient distress after treatment will be assessed by the Chemotherapy-induced Alopecia Distress Scale (CADS) scale. CADS is a 17-item self-report tool used to measure distress related to chemotherapy-induced hair loss across four domains: physical, emotional, activity, and relationship. Participants rate experiences, difficulties, or distress due to hair loss using a 4-point Likert scale ranging from 1 ("Not at all") to 4 ("Very much"), yielding an overall scoring range of 17-68, such that higher CADS scores are associated with higher distress. Results will be summarized by study arm using basic descriptive statistics.
4 weeks, 8 weeks, 12 weeks, and 26 weeks after completion of chemotherapy, up to ~11 months total (from the start to completion of chemotherapy)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gene expression changes in chemotherapy-induced and persistent chemotherapy-induced alopecia
Time Frame: 26 weeks after completion of chemotherapy
Using a non-invasive method of plucked hair follicles, the investigators will interrogate patients' hair follicle transcriptome at 26 weeks after chemotherapy completion to clarify persistent chemotherapy-induced alopecia pathogenesis. The investigators will also identify predictive markers for cooling success through transcriptome profiling on hair follicles before and after chemotherapy in intervention and control groups.
26 weeks after completion of chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Collaborators

Paxman Coolers Limited

Investigators

  • Principal Investigator: Beth McLellan, MD, Montefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2022

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

December 2, 2021

First Submitted That Met QC Criteria

January 17, 2022

First Posted (Actual)

January 28, 2022

Study Record Updates

Last Update Posted (Actual)

July 16, 2026

Last Update Submitted That Met QC Criteria

July 14, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-13614

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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