title: Randomized trial of vitamin B6 for preventing hand-foot syndrome from capecitabine chemotherapy.
abstract: BACKGROUND
  Capecitabine is an oral fluoropyrimidine that is used to treat various malignancies. Hand-foot syndrome (HFS) is a dose-limiting toxicity of capecitabine that can limit the use of this agent in some patients. Some investigators have observed that pyridoxine (vitamin B6) can ameliorate HFS that is caused by capecitabine. We designed a prospective trial to determine if pyridoxine can prevent HFS in patients who receive capecitabine.
  
  
  METHODS
  In our double-blind, placebo-controlled trial, we randomly assigned eligible patients who were treated with capecitabine to receive either daily pyridoxine 100 mg or placebo along with their capecitabine-containing chemotherapy regimen. Patients were observed during the first 4 cycles of capecitabine treatment. The primary endpoint was the incidence and grade of HFS that occurred in both study arms.
  
  
  RESULTS
  Between 2008 and 2011, 77 patients were randomly assigned to receive either pyridoxine (n = 38) or placebo (n = 39). Dosages of capecitabine were equally matched between both arms of the study. HFS occurred after a median of 2 chemotherapy cycles in both groups. HFS developed in 10 of 38 (26%) patients in the pyridoxine group and in 8 of 39 (21%) patients in the placebo group (P = .547). Therefore, the risk of HFS was 5 percentage points higher in pyridoxine group (95% confdence interval [CI] for difference, -13 percentage points to +25 percentage points). Given our study results, a true benefit from pyridoxine can be excluded. No difference in HFS grades was observed.
  
  
  CONCLUSIONS
  Single-institution study.
  
  
  CONCLUSIONS
  Prophylactic pyridoxine (vitamin B6), given concomitantly with capecitabine-containing chemotherapy, was not effective for the prevention of HFS.
authors: Hematology and Oncology Division, John H Stroger Jr Hospital of Cook County, Chicago, IL USA Email: tareqbk410@hotmail.com.
authors: Tareq
authors: T
authors: Braik
authors: Barbara
authors: B
authors: Yim
authors: Arthur T
authors: AT
authors: Evans
authors: Mohammed
authors: M
authors: Kassem
authors: Michael
authors: M
authors: Mullane
authors: Thomas
authors: T
authors: Lad
authors: Lily
authors: L
authors: Hussein
authors: Barbara
authors: B
authors: Cleveland
authors: Susan
authors: S
authors: McDunn