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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 because the information has not been verified recently.
Verified August 2009 by John H. Stroger Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
John H. Stroger Hospital
ClinicalTrials.gov Identifier:
NCT00767689
First received: October 6, 2008
Last updated: August 3, 2009
Last verified: August 2009
History of Changes
  Purpose

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

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The severity of hand and foot syndrome in patients receiving capecitabine [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00767689

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

Locations
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

No publications provided

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
Study First Received: October 6, 2008
Last Updated: August 3, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Vitamin B 6
Pyridoxine
Pyridoxal
Vitamin B Complex
Vitamins
 Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013