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Open (Enrolling)
Both
Hand and Foot Syndrome

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Trial Information


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the incidence of vitamine B6 in patient receiving vitamin b6

Outcome Time Frame:

1 year

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

08-069

NCT ID:

NCT00767689

Start Date:

May 2008

Completion Date:

May 2010

Related Keywords:

  • Hand and Foot Syndrome

Name

Location

John H Stroger Jr Hospital of Cook County Chicago, Illinois  60612-3785