Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Capecitabine for Advanced Colorectal Cancer or Breast Cancer
NCT00559858 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 270
Last updated 2013-08-02
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.
Conditions
- Breast Cancer
- Colorectal Cancer
- Palmar-plantar Erythrodysesthesia
Interventions
- DIETARY_SUPPLEMENT
-
pyridoxine hydrochloride
- OTHER
-
placebo
- PROCEDURE
-
quality-of-life assessment
Sponsors & Collaborators
-
Cambridge University Hospitals NHS Foundation Trust
lead OTHER
Principal Investigators
-
Pippa Corrie, PhD, FRCP · Cambridge University Hospitals NHS Foundation Trust
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-12-31
- Primary Completion
- 2009-12-31
Countries
- United Kingdom
Study Locations
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