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

NCT00486213 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2015-09-24

No results posted yet for this study

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.

Conditions

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

Interventions

DIETARY_SUPPLEMENT

pyridoxine hydrochloride

Pyridoxine (200mg) or placebo once daily orally for 21 days out of each treatment cycle

OTHER

Placebo

Sponsors & Collaborators

  • National Cancer Centre, Singapore

    lead OTHER

Principal Investigators

  • Yoon-Sim Yap, FRACP, MBBS · National Cancer Centre, Singapore

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00486213 on ClinicalTrials.gov