Prophylactic pyridoxine for hand-foot syndrome in patients treated with capacitabine for locally advanced or metastatic breast cancer

Phase 2

• Conditions: ocally advanced or metastatic breast cancer

• Registration Number: JPRN-UMIN000002932
• Lead Sponsor: Tokai Breast Cancer Clinical Research Group (TBCRG)

Brief Summary

A total of 135 patients were randomized to the pyridoxine (n = 67) or no pyridoxine (n = 68) groups. Grade 2 or worse HFS developed in 19 of 66 patients (28.8%) versus 21 of 67 patients (31.3%) in the pyridoxine and no pyridoxine groups, respectively. The median time to onset of grade 2 or worse HFS was 13.6 and 10.6 months in the pyridoxine and no pyridoxine groups, respectively.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-01-01
• Study Completion: 2012-06-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 135

Inclusion Criteria

Not provided

Exclusion Criteria

1.History of serious drug hypersensitivity or a history of drug allergy by fluoropyrimidine. History of adverse drug reaction caused by fluoropyrimidines with suspected dihydropyrimidine dehydrogenase deficiency 2.Capecitabine used prior chemotherapy 3.History of drug hypersensitivity not suitable for this study 4.Uncontrolled serious complications 5.Multiple primary cancer within 5 years 6.Pregnant women or possibly pregnant women 7.Other conditions not suitable for this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified