Ignite Creation Date:
2024-05-06 @ 12:16 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03711877
Status:
UNKNOWN
Last Update Posted:
2021-11-29
First Post:
2018-10-11
Brief Title:
Comparative Study of Scalp Cooling System and Chemical Cold Cap COHAIR Study
Sponsor:
Tao OUYANG
Organization:
Peking University
Study Overview
Official Title:
Comparative Study of Scalp Cooling System and Chemical Cold Cap on Prevention of Chemotherapy-induced Alopecia in Women With Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2021-11
Last Known Status:
RECRUITING
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:
COHAIR
Brief Summary:
This is a phase III single-center prospective open-label randomizedcontrolled study
Detailed Description:
To conduct a prospective randomized controlled study comparing the effect of scalp cooling system DigniCap and chemical cold cap on preventing chemotherapy-induced alopecia in a group of breast cancer patients receiving standard anthracycline followed paclitaxel regimens To obtain the exact data on the role of different methods of preventing alopecia in Chinese women with breast cancer
PASS 11 software was used to calculate the sample size According to the results of previous studies the hair retention rate of the cold cap group was 677 the hair retention rate of the scalp cooling system group was 505 α005Power08 The sample size was calculated to be at least 128 cases in each group 256 cases in total
PASS 11 software was used to calculate the sample size According to the results of previous studies the hair retention rate of the cold cap group was 677 the hair retention rate of the scalp cooling system group was 505 α005Power08 The sample size was calculated to be at least 128 cases in each group 256 cases in total
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None