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

This study is currently recruiting participants.

Verified by John H. Stroger Hospital, October 2008

First Received: October 6, 2008 No Changes Posted

Sponsored by:	John H. Stroger Hospital
Information provided by:	John H. Stroger Hospital
ClinicalTrials.gov Identifier:	NCT00767689

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

MedlinePlus related topics: Cancer Foot Health

Drug Information available for: Pyridoxine hydrochloride Pyridoxine Vitamin B 6

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

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 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
vitamin B6: Experimental patient receiving xeloda and vitamin B6	Drug: vitamin b6 vitamin b6 100 mg po daily
2 placebo: Placebo Comparator 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:	John H. Stroger Jr Hospital of cook county ( Dr Susan McDunn )
Study ID Numbers:	08-069
Study First Received:	October 6, 2008
Last Updated:	October 6, 2008
ClinicalTrials.gov Identifier:	NCT00767689 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Capecitabine
Vitamin B Complex
Pyridoxal
Vitamins

Trace Elements
Pyridoxine
Micronutrients
Vitamin B 6

Additional relevant MeSH terms:

Vitamin B Complex
Pathologic Processes
Disease
Pyridoxal
Growth Substances
Vitamins

Syndrome
Physiological Effects of Drugs
Pyridoxine
Micronutrients
Pharmacologic Actions
Vitamin B 6

ClinicalTrials.gov processed this record on May 07, 2009