Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color

NCT ID: NCT05213936

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-24
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Scalp cooling with hairstyle

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

Group Type: EXPERIMENTAL

Scalp cooling with hairstyle

Intervention Type: 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

Scalp cooling after coating hair with conditioner and water emulsion to minimize hair volume and increase scalp cooling cap to scalp contact

Group Type: EXPERIMENTAL

Scalp cooling with conditioner and water emulsion

Intervention Type: 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.

No Scalp Cooling

Control with no scalp cooling

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Scalp cooling with hairstyle

Hair will be prepared accordingly for the cooling cap fitting based on which approach the patient prefers: braids/cornrows/twists

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Paxman

UNKNOWN

Sponsor Role: collaborator

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beth McLellan, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

Montefiore Medical Center

The Bronx, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Beth McLellan, MD

Role: CONTACT

bmclella@montefiore.org

(718) 862-8840

Yana Kost, BA

Role: CONTACT

yana.kost@einsteinmed.org

240-383-6896

Facility Contacts

Warner Robinson, DMD

Role: primary

warrobinso@montefiore.org

786-385-7775

Other Identifiers

2021-13614

Identifier Type: -

Identifier Source: org_study_id