Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color
ConditionAlopecia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMontefiore Medical Center
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Scalp cooling with hairstyle
DeviceHair 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
DeviceHair will be prepared accordingly for the fitting based on which approach the patient prefers: or conditioner and water emulsion to coat the hair.
Treatment groups
41 Participants
are divided into 3 treatment groupsGroup A: Scalp cooling with hairstyleExperimental treatment 1 intervention
Group B: Scalp Cooling with conditioner and water emulsionExperimental treatment 1 intervention
Group C: No Scalp CoolingNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Severity of chemotherapy-induced alopecia - hair count density
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.
Time frame
4 weeks after completion of chemotherapy, up to ~6 months total2
Severity of chemotherapy-induced alopecia - adverse events
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.
Time frame
4 weeks after the completion of chemotherapy, up to ~6 months totalSecondary outcomes
1
Severity of persistent chemotherapy-induced alopecia (PCIA) - hair count density
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.
Time frame
26 weeks after completion of chemotherapy, up to ~11 months total2
Severity of persistent chemotherapy-induced alopecia - adverse events
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.
Time frame
26 weeks after completion of chemotherapy, up to ~11 months total3
Patient distress after treatment
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.
Time frame
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)Other outcomes
1
Gene expression changes in chemotherapy-induced and persistent chemotherapy-induced alopecia
Using a non-invasive method of plucked hair follicles, the investigators will interrogate patients' hair follicle transcriptome at 26 weeks after chemotherapy completion to clarify persistent chemotherapy-induced alopecia pathogenesis. The investigators will also identify predictive markers for cooling success through transcriptome profiling on hair follicles before and after chemotherapy in intervention and control groups.
Time frame
26 weeks after completion of chemotherapySponsors and contacts
Click on the lead sponsor to view all of their trials.
Montefiore Medical Center
Lead sponsor
Paxman Coolers Limited
Collaborator
Source ClinicalTrials.gov