NCT00559858

Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Capecitabine for Advanced Colorectal Cancer or Breast Cancer

A Randomised Placebo-controlled Study Evaluating the Role of Pyridoxine in Controlling Capecitabine-induced Hand-foot Syndrome

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: Cambridge University Hospitals NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Pyridoxine (vitamin B6) may prevent or lessen hand-foot syndrome caused by chemotherapy. It is not yet known whether pyridoxine is more effective than a placebo in preventing hand-foot syndrome. PURPOSE: This phase III randomized trial is studying pyridoxine to see how well it works compared to a placebo in preventing hand-foot syndrome in patients who are receiving capecitabine for advanced colorectal cancer or breast cancer.

Detailed description

OBJECTIVES: Primary * Determine whether pyridoxine can reduce the incidence of capecitabine dose modifications (dose delay and dose reductions) due to toxicity. Secondary * Determine the incidence of hand-foot syndrome (HFS). * Determine the overall toxicity. * Determine the quality of life. * Determine the response to chemotherapy. * Determine the progression-free survival. * Determine the level of biomarkers which might predict the occurrence of HFS. OUTLINE: This is a multicenter study. Patients are stratified according to disease (breast cancer vs colorectal cancer). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral pyridoxine hydrochloride 3 times daily beginning with the initiation of capecitabine chemotherapy and continuing until completion of chemotherapy. * Arm II: Patients receive oral placebo 3 times daily beginning with the initiation of capecitabine chemotherapy and continuing until completion of chemotherapy. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity. Evidence of hand-foot syndrome is assessed at baseline and before each course of capecitabine. Quality of life is assessed at baseline and then every 6 weeks. After completion of study treatment, patients are followed at 6 and 12 weeks.

Conditions

• Breast Cancer
• Colorectal Cancer
• Palmar-plantar Erythrodysesthesia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	pyridoxine hydrochloride
OTHER	placebo
PROCEDURE	quality-of-life assessment

Timeline

• Start date: 2004-12-01
• Primary completion: 2009-12-01
• First posted: 2007-11-16
• Last updated: 2013-08-02

Locations

16 sites across 1 country: United Kingdom