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



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:4/2/2016
Start Date:May 2008
End Date:May 2010
Contact:Tareq Braik, MD
Email:tareqbk410@hotmail.com
Phone:312-8390060

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Trial Summary
Trial Overview
Inclusion Criteria

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.


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
We found this trial at
1
site
John H. Stroger, Jr. Hospital of Cook County
1969 W Ogden Ave
Chicago, Illinois 60612
(312) 864-6000
John H. Stroger, Jr. Hospital of Cook County The Level 1 Trauma Center is one...
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Chicago, IL
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