A Randomised Placebo-controlled Study Evaluating the Role of Pyridoxine in Controlling Capecitabine-induced Hand-foot Syndrome
- Determine whether pyridoxine can reduce the incidence of capecitabine dose
modifications (dose delay and dose reductions) due to toxicity.
- Determine the incidence of hand-foot syndrome (HFS).
- Determine the overall toxicity.
- Determine the quality of life.
- Determine the response to chemotherapy.
- Determine the progression-free survival.
- Determine the level of biomarkers which might predict the occurrence of HFS.
OUTLINE: This is a multicenter study. Patients are stratified according to disease (breast
cancer vs colorectal cancer). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral pyridoxine hydrochloride 3 times daily beginning with the
initiation of capecitabine chemotherapy and continuing until completion of
- Arm II: Patients receive oral placebo 3 times daily beginning with the initiation of
capecitabine chemotherapy and continuing until completion of chemotherapy.
In both arms, treatment continues in the absence of disease progression or unacceptable
Evidence of hand-foot syndrome is assessed at baseline and before each course of
capecitabine. Quality of life is assessed at baseline and then every 6 weeks.
After completion of study treatment, patients are followed at 6 and 12 weeks.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Incidence of capecitabine dose modifications (dose delay and dose reductions) due to toxicity
Pippa Corrie, PhD, FRCP
Cambridge University Hospitals NHS Foundation Trust
United States: Federal Government