Clinical trial NCT05213936: Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color
Official title: Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color: A Clinical and Mechanistic Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alopecia
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Paxman
First posted: 2022-01-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Severity of chemotherapy-induced alopecia
timeFrame: 6 months after completing treatment, up to approximately 11 months total (from the start to completion of chemotherapy)
measure: Patient distress during treatment
timeFrame: 6 months after completing treatment, up to approximately 11 months (from the start to completion of chemotherapy)
Secondary outcomes:
measure: Severity of persistent chemotherapy-induced alopecia
timeFrame: 26 weeks (starting after chemotherapy completion)
measure: Patient distress after treatment
timeFrame: 26 weeks (starting after chemotherapy completion)
Other outcomes:
measure: Gene expression changes in chemotherapy-induced and persistent chemotherapy-induced alopecia
timeFrame: 26 weeks (starting after chemotherapy completion)
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Beth McLellan, MD
role: PRINCIPAL_INVESTIGATOR
References: