Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color

Alopecia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05213936
• Other study ID #: 2021-13614
• Status: Recruiting
• Phase: N/A
• Start date: October 24, 2022
• Est. completion date: January 2025

Study information

• Verified date: December 2023
• Source: Montefiore Medical Center
• Contact: Beth McLellan, MD
• Phone: (718) 862-8840
• Email: bmclella[@]montefiore.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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-induced alopecia molecular mechanisms using non-invasive transcriptome sequencing on plucked hair follicles.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age > 18 years

2. Hair type 3 (curly) or type 4 (kinky)

3. Diagnosis of breast or non-small cell lung cancer (NSCLC) stage I-III

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

a. Concurrent HER, cisplatin, and cyclophosphamide therapies allowed

5. 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. Use of hair weave or extensions without plans to remove

3. Diagnosis of breast cancer or NSCLC stage IV

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 or administration of anthracyclines (doxorubicin)

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Montefiore Medical Center	Paxman

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Primary	Severity of chemotherapy-induced alopecia	Determined by hair counts with trichoscopy with measurements of hair shaft diameter & follicle density and Common Terminology Criteria for Adverse Events grading	Up to approximately 11 months (from the start to completion of chemotherapy)
Primary	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	Up to approximately 11 months (from the start to completion of chemotherapy)
Secondary	Severity of persistent chemotherapy-induced alopecia	Determined by hair counts with trichoscopy with measurements of hair shaft diameter & follicle density and Common Terminology Criteria for Adverse Events grading 26 weeks after chemotherapy completion	26 weeks (starting after chemotherapy completion)
Secondary	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)