Ignite Creation Date:
2024-05-06 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04690283
Status:
UNKNOWN
Last Update Posted:
2020-12-30
First Post:
2020-12-13
Brief Title:
Yiqi Wenjing Prescriptions Preventive Efficacy of Oxaliplatin-induced Peripheral Neuropathy Clinical Trial
Sponsor:
Nanjing NingQi Medicine Science and Technology Co Ltd
Organization:
Nanjing NingQi Medicine Science and Technology Co Ltd
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Multicenter Phase Ⅲ Clinical Trial of Yiqi Wenjing Prescriptions for Preventing Oxaliplatin-induced Peripheral Neuropathy
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
NOT_YET_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:
YWPPEOPNCT
Brief Summary:
This study is a randomized placebo-controlled double-blind multicenter phase III clinical trial of Yiqi Wenjing prescriptions for Preventing Oxaliplatin-induced Peripheral Neuropathy
Detailed Description:
This study is a randomized placebo-controlled double-blind and multicenter clinical trial Three hundred sixty postoperative patients with colon cancer stage IIa-IIIc will be randomly assigned into treatment group I treatment group II and placebo-control group taking Huangqi Guizhi Wuwu granules Danggui Sini granules and the mimetic granules of Yiqi Wenjing granules respectively All subjects will receive mFOLFOX6 or FOLFOX4 or XELOX chemotherapy regimen along with traditional Chinese medicineTCM or placebo treatment per day for at least three months and one year follow up EORTC QLQ-CIPN20 will be used to assess the degree of peripheral neuropathy as the primary outcome measure Grades of OIPN evaluated by NCI-CTCAE 50 quality of life evaluated by EORTC QLQ-C30 chemotherapeutic efficacy evaluated by RESIST 11 and the number of completed chemotherapy cycles are selected as the secondary outcome measures
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?:
False
Is an FDA AA801 Violation?:
None