Ignite Creation Date:
2024-05-06 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05213936
Status:
RECRUITING
Last Update Posted:
2023-12-28
First Post:
2021-12-02
Brief Title:
Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color
Sponsor:
Montefiore Medical Center
Organization:
Montefiore Medical Center
Study Overview
Official Title:
Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color A Clinical and Mechanistic Study
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 cornrowsbraidstwists or 2 waterconditioner 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
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 cornrowsbraidstwists or 2 waterconditioner 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None