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NCT Number: NCT05213936

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 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.

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Key information

Conditions

Alopecia Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location status: Recruiting

Location contact

Warner Robinson, DMD

CONTACT

[email protected]

786-385-7775

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Beth McLellan, MD

CONTACT

[email protected]

(718) 862-8840

Yana Kost, BA

CONTACT

[email protected]

240-383-6896

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Collaborators

  • Paxman Coolers Limited

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jan 28, 2022
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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