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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2009 by John H. Stroger Hospital.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: October 7, 2008
Last Update Posted: August 6, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
John H. Stroger Hospital
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.

Condition Intervention
Hand and Foot Syndrome Drug: vitamin b6 Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:

Further study details as provided by John H. Stroger Hospital:

Primary Outcome Measures:
  • To determine the incidence of vitamine B6 in patient receiving vitamin b6 [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • The severity of hand and foot syndrome in patients receiving capecitabine [ Time Frame: 1 year ]

Estimated Enrollment: 96
Study Start Date: May 2008
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vitamin B6
patient receiving xeloda and vitamin B6
Drug: vitamin b6
vitamin b6 100 mg po daily
Placebo Comparator: 2 placebo
patient receiving xeloda and placebo
Drug: placebo
placebo is given in the placebo arm


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00767689

Contact: Tareq Braik, MD 312-8390060 tareqbk410@hotmail.com

United States, Illinois
John H stroger Jr hospital of cook county Recruiting
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
John H. Stroger Hospital
  More Information

Responsible Party: Dr Susan McDunn, John H. Stroger Jr Hospital of cook county
ClinicalTrials.gov Identifier: NCT00767689     History of Changes
Other Study ID Numbers: 08-069
First Submitted: October 6, 2008
First Posted: October 7, 2008
Last Update Posted: August 6, 2009
Last Verified: August 2009

Additional relevant MeSH terms:
Hand-Foot Syndrome
Pathologic Processes
Drug Eruptions
Skin Diseases
Drug Hypersensitivity
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Vitamin B 6
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs