Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color

NCT05213936 | Recruiting FDA Device

• 1 other identifier: 2021-13614
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alopecia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Severity of persistent chemotherapy-induced alopecia

  26 weeks (starting after chemotherapy completion)

• Patient distress after treatment

  26 weeks (starting after chemotherapy completion)

Other Outcomes (1)

• Gene expression changes in chemotherapy-induced and persistent chemotherapy-induced alopecia

  26 weeks (starting after chemotherapy completion)

Study Arms (3)

Scalp cooling with hairstyle

EXPERIMENTAL

Scalp cooling with hairstyle (braids, twists, cornrows) to minimize hair volume and increase scalp cooling cap to scalp contact

Device: Scalp cooling with hairstyle

Scalp Cooling with conditioner and water emulsion

EXPERIMENTAL

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

No Scalp Cooling

NO INTERVENTION

Control with no scalp cooling

Interventions

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 hairstyle

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.

Scalp Cooling with conditioner and water emulsion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead
• Paxman: collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10461, United States

RECRUITING

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

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

Study Officials

• Beth McLellan, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beth McLellan, MD

CONTACT

(718) 862-8840; bmclella@montefiore.org

Yana Kost, BA

CONTACT

240-383-6896; yana.kost@einsteinmed.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Hair counts using trichoscopy and photographs will be taken at baseline and at the beginning of each chemotherapy cycle, which will be graded by two independent clinicians blinded to the patient group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: January 28, 2022
• Study Start: October 24, 2022
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 15, 2025

Record last verified: 2025-01

Locations

US (1)