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

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

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

• NCT number: NCT00486213
• Study type: Interventional
• Source: National Cancer Centre, Singapore
• Status: Terminated
• Phase: Phase 3
• Start date: June 2007
• Completion date: August 2014