NCT00486213

Pyridoxine in Preventing Hand-Foot Syndrome Caused by Capecitabine in Patients With Cancer

Randomized Double-Blind Placebo-Controlled Trial of Pyridoxine for Prevention of Capecitabine-Induced Hand-Foot Syndrome (HFS)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: National Cancer Centre, Singapore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Pyridoxine may help prevent hand-foot syndrome caused by capecitabine in patients with cancer. It is not yet known whether pyridoxine is more effective than a placebo in preventing hand-foot syndrome in patients with cancer. PURPOSE: This randomized phase III trial is studying pyridoxine to see how well it works compared with a placebo in preventing hand-foot syndrome caused by capecitabine in patients with cancer.

Detailed description

OBJECTIVES: Primary * Compare the incidence of capecitabine-induced palmar-plantar erythrodysesthesia (hand-foot syndrome \[HFS\]) ≥ grade 2 in patients with cancer treated with pyridoxine hydrochloride vs placebo. Secondary * Compare the time to onset of HFS ≥ grade 2 in patients treated with these regimens. * Compare the quality of life changes in patients treated with these regimens. * Identify factors predicting toxicity from capecitabine chemotherapy. OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to gender and treatment setting (adjuvant/neoadjuvant vs palliative setting). Patients are randomized to 1 of 2 treatment arms. * Arm I: Beginning concurrently with planned capecitabine treatment, patients receive oral pyridoxine hydrochloride once daily on days 1-21. * Arm II: Beginning concurrently with planned capecitabine treatment, patients receive oral placebo once daily on days 1-21. In both arms, treatment repeats every 21 days for up to 8 courses (until discontinuation of capecitabine treatment). Quality of life is assessed at baseline, at the beginning of courses 2, 4, 6, and 8, and at the end of the study.

Conditions

• Dermatologic Complications
• Palmar-plantar Erythrodysesthesia
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	pyridoxine hydrochloride	Pyridoxine (200mg) or placebo once daily orally for 21 days out of each treatment cycle
OTHER	Placebo

Timeline

• Start date: 2007-06-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2007-06-14
• Last updated: 2015-09-24

Locations

1 site across 1 country: Singapore