Alopecia
Conditions
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.
Interventions
DEVICEScalp cooling with hairstyle
Hair will be prepared accordingly for the cooling cap fitting based on which approach the patient prefers: braids/cornrows/twists
DEVICEScalp 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.
Sponsors
Montefiore Medical Center
Paxman Coolers Limited
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of chemotherapy-induced alopecia - hair count density | 4 weeks after completion of chemotherapy, up to ~6 months total | Severity of chemotherapy-induced alopecia, or CIA, as determined by hair count density from trichoscopy will be assessed. Hair count density (hair counts/cm\^2) will be summarized by study arm and analyzed using a T-test. |
| Severity of chemotherapy-induced alopecia - adverse events | 4 weeks after the completion of chemotherapy, up to ~6 months total | Severity of CIA will also be evaluated based on Common Terminology Criteria for Adverse Events (CTCAE Version 5.0) grading. Results will be summarized by study arm and analyzed Fisher's exact test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of persistent chemotherapy-induced alopecia (PCIA) - hair count density | 26 weeks after completion of chemotherapy, up to ~11 months total | Severity of PCIA, as determined by hair count density from trichoscopy will be assessed. Hair count density (hair counts/cm\^2) will be summarized by study arm and analyzed using a T-test. |
| Severity of persistent chemotherapy-induced alopecia - adverse events | 26 weeks after completion of chemotherapy, up to ~11 months total | Severity of PCIA will also be evaluated based on Common Terminology Criteria for Adverse Events (CTCAE Version 5.0) grading. Results will be summarized by study arm and analyzed Fisher's exact test. |
| Patient distress after treatment | 4 weeks, 8 weeks, 12 weeks, and 26 weeks after completion of chemotherapy, up to ~11 months total (from the start to completion of chemotherapy) | Patient distress after treatment will be assessed by the Chemotherapy-induced Alopecia Distress Scale (CADS) scale. CADS is a 17-item self-report tool used to measure distress related to chemotherapy-induced hair loss across four domains: physical, emotional, activity, and relationship. Participants rate experiences, difficulties, or distress due to hair loss using a 4-point Likert scale ranging from 1 ("Not at all") to 4 ("Very much"), yielding an overall scoring range of 17-68, such that higher CADS scores are associated with higher distress. Results will be summarized by study arm using basic descriptive statistics. |
Countries
United States
Contacts
CONTACTBeth McLellan, MD
CONTACTYana Kost, BA
PRINCIPAL_INVESTIGATORBeth McLellan, MD
Montefiore Medical Center
Outcome results
None listed