Ignite Creation Date:
2024-05-06 @ 7:34 AM
Last Modification Date:
2024-10-26 @ 11:50 AM
Study NCT ID:
NCT02560740
Status:
TERMINATED
Last Update Posted:
2016-12-14
First Post:
2015-08-15
Brief Title:
A Study of the Efficacy and Safety of PerOx Quench on the Prevention of Oxaliplatin Treatment Induced Neuropathy
Sponsor:
SMR Biotech Co Ltd
Organization:
SMR Biotech Co Ltd
Study Overview
Official Title:
A Randomised Double-blinded Placebo Controlled Study to Assess the Efficacy and Safety of PerOx Quench or Placebo for 35 Days on the Prevention of Oxaliplatin Treatment Induced Sensory Neuropathy
Status:
TERMINATED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Subjects not-well compliance due to diarrhea and softening stool after taking PerOx Quench 4 sachets a day
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Chemotherapy-induced peripheral neuropathy CIPN is a progressive enduring and often irreversible condition featuring pain numbness tingling and sensitivity to cold in the hands and feet sometimes progressing to the arms and legs that afflicts between 30 and 40 percent of patients undergoing chemotherapy
American Society of Clinical Oncology ASCO guidance on The Journal of Clinical Oncology JCO 2014 April 14 does not recommend any prophylaxis regimen for CIPN
PerOx Quench has unique membrane protection and anti-oxidative function as a special food thats why to try to explore its preventive effects on CIPN prevention induced by Oxaliplatin for colorectal cancer or gastric cancer chemotherapy
American Society of Clinical Oncology ASCO guidance on The Journal of Clinical Oncology JCO 2014 April 14 does not recommend any prophylaxis regimen for CIPN
PerOx Quench has unique membrane protection and anti-oxidative function as a special food thats why to try to explore its preventive effects on CIPN prevention induced by Oxaliplatin for colorectal cancer or gastric cancer chemotherapy
Detailed Description:
This study uses two stage group-sequential sampling design based on current data assumed the CIPN incidence rate is 50 in placebo arm while 20 in PerOx Quench arm60 reduction set a00580 power random allocation ratio is 11 obtained the subjects number is 41total 82 by PASS 11 software for superior design considering 10 drop out rate final number of subjects totally is 90
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