Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2026-01-04 @ 5:43 AM
Study NCT ID:
NCT03768492
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-30
First Post:
2018-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Safety and Efficacy of a Caffeine-based Antifibrosis Cream in Patients With Breast Cancer Undergoing Radiation Therapy
Sponsor:
NYU Langone Health
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Double Blinded, Placebo Controlled Study of the Safety and Efficacy of a Caffeine-based Antifibrosis Cream in Patients With Breast Cancer Undergoing Radiation Therapy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-07
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:
ReDCoAT
Brief Summary:
The purpose of the study is to evaluate whether a caffeine-based cream can reduce the rates of reconstructive complications in patients with tissue expander based reconstruction requiring post-mastectomy radiation therapy when compared to a placebo cream.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: