Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color
Primary Purpose
Alopecia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Scalp cooling with hairstyle
Scalp cooling with conditioner and water emulsion
Sponsored by
About this trial
This is an interventional treatment trial for Alopecia
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
Sites / Locations
- Montefiore Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Scalp cooling with hairstyle
Scalp Cooling with conditioner and water emulsion
No Scalp Cooling
Arm Description
Scalp cooling with hairstyle (braids, twists, cornrows) to minimize hair volume and increase scalp cooling cap to scalp contact
Scalp cooling after coating hair with conditioner and water emulsion to minimize hair volume and increase scalp cooling cap to scalp contact
Control with no scalp cooling
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT05213936
First Posted
December 2, 2021
Last Updated
December 22, 2022
Sponsor
Montefiore Medical Center
Collaborators
Paxman
1. Study Identification
Unique Protocol Identification Number
NCT05213936
Brief Title
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
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 24, 2022 (Actual)
Primary Completion Date
January 3, 2024 (Anticipated)
Study Completion Date
January 3, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center
Collaborators
Paxman
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Scalp cooling with hairstyle
Arm Type
Experimental
Arm Description
Scalp cooling with hairstyle (braids, twists, cornrows) to minimize hair volume and increase scalp cooling cap to scalp contact
Arm Title
Scalp Cooling with conditioner and water emulsion
Arm Type
Experimental
Arm Description
Scalp cooling after coating hair with conditioner and water emulsion to minimize hair volume and increase scalp cooling cap to scalp contact
Arm Title
No Scalp Cooling
Arm Type
No Intervention
Arm Description
Control with no scalp cooling
Intervention Type
Device
Intervention Name(s)
Scalp cooling with hairstyle
Intervention Description
Hair will be prepared accordingly for the cooling cap fitting based on which approach the patient prefers: braids/cornrows/twists
Intervention Type
Device
Intervention Name(s)
Scalp cooling with conditioner and water emulsion
Intervention Description
Hair will be prepared accordingly for the fitting based on which approach the patient prefers: or conditioner and water emulsion to coat the hair.
Primary Outcome Measure Information:
Title
Severity of chemotherapy-induced alopecia
Description
Determined by hair counts with trichoscopy with measurements of hair shaft diameter & follicle density and Common Terminology Criteria for Adverse Events grading
Time Frame
Up to approximately 11 months (from the start to completion of chemotherapy)
Title
Patient distress during treatment
Description
Assessed by the Chemotherapy Alopecia Distress Scale and patient self-assessment of hair growth using Common Terminology Criteria for Adverse Events
Time Frame
Up to approximately 11 months (from the start to completion of chemotherapy)
Secondary Outcome Measure Information:
Title
Severity of persistent chemotherapy-induced alopecia
Description
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
Time Frame
26 weeks (starting after chemotherapy completion)
Title
Patient distress after treatment
Description
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
Time Frame
26 weeks (starting after chemotherapy completion)
Other Pre-specified Outcome Measures:
Title
Gene expression changes in chemotherapy-induced and persistent chemotherapy-induced alopecia
Description
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 (starting after chemotherapy completion)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beth McLellan, MD
Phone
(718) 862-8840
Email
bmclella@montefiore.org
First Name & Middle Initial & Last Name or Official Title & Degree
Yana Kost, BA
Phone
240-383-6896
Email
yana.kost@einsteinmed.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beth McLellan, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Warner Robinson, DMD
Phone
786-385-7775
Email
warrobinso@montefiore.org
12. IPD Sharing Statement
Learn more about this trial
Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color
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