Ignite Creation Date:
2024-05-06 @ 7:43 AM
Last Modification Date:
2024-10-26 @ 11:51 AM
Study NCT ID:
NCT02580279
Status:
UNKNOWN
Last Update Posted:
2019-04-05
First Post:
2015-09-27
Brief Title:
Study of Epigallocatechin-3-gallate EGCG for Skin Prevention in Patients With Breast Cancer Receiving Adjuvant Radiotherapy
Sponsor:
Shandong Cancer Hospital and Institute
Organization:
Shandong Cancer Hospital and Institute
Study Overview
Official Title:
Phase II Study of Topical Epigallocatechin-3-gallate EGCG in Patients With Breast Cancer Receiving Adjuvant Radiotherapy
Status:
UNKNOWN
Status Verified Date:
2019-04
Last Known Status:
ENROLLING_BY_INVITATION
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 investigators conduct this phase II study of EGCG therapy protection of the skin from damage induced by radiotherapy in breast cancer In order to observe the effectiveness of EGCG investigators will utilize both clinician assessments and patient self-assessments Physicians skin assessments will be scored utilizing the Radiation Therapy Oncology Group RTOG score Patient reported symptom scores are adapted from the Skin Toxicity Assessment Tool STAT as pain burning itching pulling and tenderness in the treatment area The scales are translated into Chinese and guides in Chinese are developed instructing how to use the scales and perform the assessments
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None