NCT00767689

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

A Randomized Trial to Determine if Vitamin B6 Can Prevent Hand and Foot Syndrome in Cancer Patients Treated With Capecitabine Chemotherapy

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Cook County Health · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Hand and Foot Syndrome

Interventions

Type	Name	Description
DRUG	Vitamin B 6	vitamin b6 100 mg po daily
DRUG	placebo	placebo is given in the placebo arm

Timeline

• Start date: 2006-03-21
• Primary completion: 2009-03-18
• Completion: 2010-03-17
• First posted: 2008-10-07
• Last updated: 2023-06-15

Locations

1 site across 1 country: United States