Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00446147
Status:
COMPLETED
Last Update Posted:
2014-02-25
First Post:
2007-03-09
Brief Title:
Study of Pyridoxine for Hand-Foot Syndrome
Sponsor:
Asan Medical Center
Organization:
Asan Medical Center
Study Overview
Official Title:
Double-Blind Phase III Study of Pyridoxine vs Placebo for the Prevention of Capecitabine-induced Hand-Foot Syndrome
Status:
COMPLETED
Status Verified Date:
2014-01
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:
None
Brief Summary:
Although pyridoxine has been used empirically for the prevention of capecitabine associated hand-foot syndrome HFS its efficacy needs to be demonstrated in prospective controlled trials The investigators therefore performed a prospective randomized double-blind study to determine whether pyridoxine 200 mgday can prevent the development of HFS when given concurrently with capecitabine The investigators also tested the ability of pyridoxine to treat primary occurrence of grade 2-3 HFS
Detailed Description:
Although pyridoxine has been used empirically for the prevention of capecitabine associated HFS its efficacy needs to be demonstrated in prospective controlled trials We estimated that the HFS rate with placebo and pyridoxine would be 035 and 018 respectively and we therefore calculated that a sample size of 345 patients would be necessary to detect these hazard rates with an 80 power β02 and two-sided significance level of α005 We assumed a follow up loss rate of 10 thus requiring 380 patients to be randomized Chemotherapy-naive patients with gastrointestinal tract cancers who were scheduled for capecitabine-containing chemotherapy were assigned to receive oral pyridoxine or placebo in randomized double-blind placebo controlled study Pyridoxine 100 mg bid was prescribed to the patients in the pyridoxine group identical placebo 100 mg bid was prescribed in the placebo group by the closed envelop randomization Patients were stratified by chemotherapy regimen capecitabine alone X capecitabine and cisplatin XP or docetaxel capecitabine and cisplatin DXP Patients were observed until NCI CTC grade 2 or 3 HFS developed or capecitabine-containing chemotherapy ended Patients in the placebo group who developed grade 2 or 3 HFS were randomized to receive pyridoxine or placebo for the next chemotherapy cycle to determine whether pyridoxine could improve HFS and the same treatment was continued for 2 chemotherapy cycles
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