Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color

Study Overview
=================
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.

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

Conditions
-----------------
Alopecia

Intervention / Treatment
-----------------
* Device: Scalp cooling with hairstyle
* Device: Scalp cooling with conditioner and water emulsion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Hair type 3 (curly) or type 4 (kinky) Diagnosis of breast or non-small cell lung cancer (NSCLC) stage I-III Patient will be starting >4 cycles of taxane-based chemotherapy treatment for curative intent after enrollment a. Concurrent HER, cisplatin, and cyclophosphamide therapies allowed Eastern Cooperative Oncology Group (ECOG) 0-2: fully active, restrictive in physically strenuous activity, ambulatory and capable of self-care Exclusion Criteria: Hair type other than 3 or 4 Use of hair weave or extensions without plans to remove Diagnosis of breast cancer or NSCLC stage IV Concurrent malignancy including hematologic malignancies (i.e. leukemia or lymphoma) Alopecia Common Terminology Criteria for Adverse Events > grade 1 at baseline Past chemotherapy administration or administration of anthracyclines (doxorubicin) 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Scalp cooling with hairstyle<br>Scalp cooling with hairstyle (braids, twists, cornrows) to minimize hair volume and increase scalp cooling cap to scalp contact | Device: Scalp cooling with hairstyle<br>* Hair will be prepared accordingly for the cooling cap fitting based on which approach the patient prefers: braids/cornrows/twists<br>|
| Experimental: Scalp Cooling with conditioner and water emulsion<br>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<br>* Hair will be prepared accordingly for the fitting based on which approach the patient prefers: or conditioner and water emulsion to coat the hair.<br>|
| No Intervention: No Scalp Cooling<br>Control with no scalp cooling | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) |