Vitamin B6 Can Prevent Hand and Foot Syndrome in Cancer Patients Capecitabine Chemotherapy

June 13, 2023 updated by: Pamela Gonzalez Sr Director Clinical Research Office, Cook County Health

A Randomized Trial to Determine if Vitamin B6 Can Prevent Hand and Foot Syndrome in Cancer Patients Treated With Capecitabine Chemotherapy

Capecitabine (Xeloda) a drug in cancer therapy. Its use is limited often by its toxicities. This study is asking if vitamin B6 can prevent one of the common toxicities of xeloda which is numbness and/or rash of the hands and feet, a condition called Hand and Foot syndrome. patients , starting capecitabine chemotherapy for their cancer, will participate in this study at John H. Stroger Jr. Hospital of Cook County. They will be randomized to receive either vitamin B6 or a placebo. investigators and patients will be blinded to the intervention.

Study Overview

Status

Terminated

Intervention / Treatment

Detailed Description

Double-blind, placebo-controlled trial, with randomly assignment of eligible patients who were treated with capecitabine to receive either daily pyridoxine 100 mg or placebo along with their capecitabine-containing chemotherapy regimen. Patients were observed during the first 4 cycles of capecitabine treatment. The primary endpoint was the incidence and grade of Hand-Foot Syndrome (HFS) that occurred in both study arms.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Illinois
      • Chicago, Illinois, United States, 60612
        • John H Stroger Jr Hospital of Cook County

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Any adult patient starting capecitabine-containing chemotherapy
  • Has never had capecitabine before
  • Performance status 0-2 using the ECOG classification
  • Life expectancy more than 6 months
  • Agreed to stop any vitamin supplements, apart from vitamin D.
  • Liver function studies including AST/ALT within 3x upper limit of normal
  • Signed informed consent must be obtained from participating individuals

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: vitamin B6
patient receiving xeloda and vitamin B6
vitamin b6 100 mg po daily
Other Names:
  • pyridoxine
Placebo Comparator: 2 placebo
patient receiving xeloda and placebo
placebo is given in the placebo arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Hand-Foot Syndrome (HFS)
Time Frame: 1 year
Incidence of HFS based on CTCTAE adverse event table
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grade of Hand-Foot Syndrome (HFS)
Time Frame: 1 year
Grading of HFS: Grade 1, Grade 2, Grade 3 per NCI CTCTAE V 3
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Thomas Lad, MD, Cook County Health Oncology NCORP
  • Principal Investigator: Susan McDunn, MD, Cook County Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2006

Primary Completion (Actual)

March 18, 2009

Study Completion (Actual)

March 17, 2010

Study Registration Dates

First Submitted

October 6, 2008

First Submitted That Met QC Criteria

October 6, 2008

First Posted (Estimated)

October 7, 2008

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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