Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color

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: Alopecia
• Intervention / Treatment: Device: Scalp cooling with hairstyle; Device: Scalp cooling with conditioner and water emulsion

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Beth McLellan, MD; Phone Number: (718) 862-8840; Email: bmclella@montefiore.org
• Study Contact Backup: Name: Yana Kost, BA; Phone Number: 240-383-6896; Email: yana.kost@einsteinmed.org

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Recruiting
      • Montefiore Medical Center
      • Contact: Warner Robinson, DMD; Phone Number: 786-385-7775; Email: warrobinso@montefiore.org

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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	The severity of chemotherapy-induced alopecia as determined by hair counts with trichoscopy with measurements of hair shaft diameter & follicle density and Common Terminology Criteria for Adverse Events (CTCAE Version 5.0) grading	6 months after completing treatment, up to approximately 11 months total (from the start to completion of chemotherapy)
Patient distress during treatment	Assessed by the Chemotherapy Alopecia Distress Scale and patient self-assessment of hair growth using Common Terminology Criteria for Adverse Events	6 months after completing treatment, up to approximately 11 months (from the start to completion of chemotherapy)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient distress after treatment	Assessed by the Chemotherapy Alopecia Distress Scale and patient self-assessment of hair growth using Common Terminology Criteria for Adverse Events 26 weeks after chemotherapy completion	26 weeks (starting after chemotherapy completion)
Severity of persistent chemotherapy-induced alopecia	The severity of chemotherapy-induced alopecia as determined by hair counts with trichoscopy with measurements of hair shaft diameter & follicle density and Common Terminology Criteria for Adverse Events (CTCAE Version 5.0) grading	26 weeks (starting after chemotherapy completion)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gene expression changes in chemotherapy-induced and persistent chemotherapy-induced alopecia	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 (starting after chemotherapy completion)

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Collaborators: Paxman
• Investigators: Principal Investigator: Beth McLellan, MD, Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2022
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

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): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 13, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Skin Diseases; Hypotrichosis; Hair Diseases; Alopecia Areata; Alopecia
• Other Study ID Numbers: 2021-13614

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