Ignite Creation Date:
2024-05-06 @ 3:34 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04678544
Status:
COMPLETED
Last Update Posted:
2022-12-16
First Post:
2020-11-24
Brief Title:
Cooling Cap Trial to Prevent Permanent Chemotherapy-induced Alopecia in Breast Cancer Patients
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
A Randomized Controlled Trial to Evaluate Effectiveness of Cooling Cap to Prevent Permanent Chemotherapy-induced Alopecia Among Breast Cancer Patients
Status:
COMPLETED
Status Verified Date:
2022-12
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:
This study aims to examine whether the PSCS2 is effective in reducing chemotherapy-induced alopecia in woman with breast cancer undergoing neoadjuvant or adjuvant chemotherapy Female adults who are newly diagnosed with stage 1-3 breast cancer and expected to receive Adriamycin orand Taxane will participate in the study The study design is a open label randomized controlled trial The patients will be randomly assigned to intervention or control groups Intervention patients will have applied scalp cooling during 4 or 6 cycles of their chemotherapy Primary endpoint is the effectiveness of the PSCS2 for reducing permanent chemotherapy-induced alopecia Secondary endpoints include chemotherapy-induced alopecia distress due to chemotherapy induced alopecia quality of life and patient-reported alopecia related side effect
Detailed Description:
Adjuvant chemotherapy decreases the risk of recurrence However it has distressing side effects including alopecia Chemotherapy-induced alopecia CIA is a common and distressing side effect of many chemotherapy drugs In previous study more than half of the breast cancer patients experienced higher distress due to CIA during cancer treatment and this distress was strongly associated with negative body image overall health status and psychosocial well-being Recently scalp cooling has been known to be one of the effective options for hair loss prevention However there was little information regarding the effect on prevention of permanent CIAPCIA This study aims to examine the impact of scalp cooling on prevention of PCIA as well as CIA
Female adults who are newly diagnosed with stage 1-3 breast cancer and aged less than 70 years will be screened for plan of undergoing Adriamycin orand Taxane regimen as neoadjuvant or adjuvant chemotherapy Eligible patients will be randomly assigned to intervention or control groups 21 ratio Patients in intervention group will have applied scalp cooling during 4 or 6 cycles of their chemotherapy whereas participants in control group will be observed
The objective of the study is to examine whether Paxman scalp cooling system is effective in reducing PCIA in women with breast cancer undergoing neoadjuvant or adjuvant chemotherapy In addition impact of Paxman scalp cooling on prevention of CIA alopecia-related distress quality of life and patient-reported alopecia related side effect will be also explored
Female adults who are newly diagnosed with stage 1-3 breast cancer and aged less than 70 years will be screened for plan of undergoing Adriamycin orand Taxane regimen as neoadjuvant or adjuvant chemotherapy Eligible patients will be randomly assigned to intervention or control groups 21 ratio Patients in intervention group will have applied scalp cooling during 4 or 6 cycles of their chemotherapy whereas participants in control group will be observed
The objective of the study is to examine whether Paxman scalp cooling system is effective in reducing PCIA in women with breast cancer undergoing neoadjuvant or adjuvant chemotherapy In addition impact of Paxman scalp cooling on prevention of CIA alopecia-related distress quality of life and patient-reported alopecia related side effect will be also explored
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