Vitamin B6 Can Prevent Hand and Foot Syndrome in Cancer Patients Capecitabine Chemotherapy

Not Applicable

Terminated

• Conditions: Hand and Foot Syndrome
• Interventions: Drug: placebo; Drug: Vitamin B 6

• Registration Number: NCT00767689
• Lead Sponsor: Cook County Health

Brief Summary

Capecitabine (Xeloda) a drug in cancer therapy. Its use is limited often by its toxicities. This study is asking if vitamin B6 can prevent one of the common toxicities of xeloda which is numbness and/or rash of the hands and feet, a condition called Hand and Foot syndrome. patients , starting capecitabine chemotherapy for their cancer, will participate in this study at John H. Stroger Jr. Hospital of Cook County. They will be randomized to receive either vitamin B6 or a placebo. investigators and patients will be blinded to the intervention.

Detailed Description

Double-blind, placebo-controlled trial, with randomly assignment of eligible patients who were treated with capecitabine to receive either daily pyridoxine 100 mg or placebo along with their capecitabine-containing chemotherapy regimen. Patients were observed during the first 4 cycles of capecitabine treatment. The primary endpoint was the incidence and grade of Hand-Foot Syndrome (HFS) that occurred in both study arms.

Study Timeline

• Study Start: 2006-03-21
• Study First Submitted: 2008-10-06
• Study First Submitted QC: 2008-10-06
• Study First Posted: 2008-10-07
• Primary Completion: 2009-03-18
• Study Completion: 2010-03-17
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-13
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Any adult patient starting capecitabine-containing chemotherapy
• Has never had capecitabine before
• Performance status 0-2 using the ECOG classification
• Life expectancy more than 6 months
• Agreed to stop any vitamin supplements, apart from vitamin D.
• Liver function studies including AST/ALT within 3x upper limit of normal
• Signed informed consent must be obtained from participating individuals

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2 placebo	placebo	patient receiving xeloda and placebo
vitamin B6	Vitamin B 6	patient receiving xeloda and vitamin B6

Primary Outcome Measures

Name	Time	Method
Incidence of Hand-Foot Syndrome (HFS)	1 year	Incidence of HFS based on CTCTAE adverse event table

Secondary Outcome Measures

Name	Time	Method
Grade of Hand-Foot Syndrome (HFS)	1 year	Grading of HFS: Grade 1, Grade 2, Grade 3 per NCI CTCTAE V 3

Trial Locations

Locations (1)

John H stroger Jr hospital of cook county; 🇺🇸 Chicago, Illinois, United States