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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
6
vitamin b6 100 mg po daily
placebo is given in the placebo arm
John H stroger Jr hospital of cook county
Chicago, Illinois, United States
Incidence of Hand-Foot Syndrome (HFS)
Incidence of HFS based on CTCTAE adverse event table
Time frame: 1 year
Grade of Hand-Foot Syndrome (HFS)
Grading of HFS: Grade 1, Grade 2, Grade 3 per NCI CTCTAE V 3
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.