Randomized Double-Blind Placebo-Controlled Trial of Pyridoxine for Prevention of Capecitabine-Induced Hand-Foot Syndrome (HFS)
- Compare the incidence of capecitabine-induced palmar-plantar erythrodysesthesia
(hand-foot syndrome [HFS]) ≥ grade 2 in patients with cancer treated with pyridoxine
hydrochloride vs placebo.
- Compare the time to onset of HFS ≥ grade 2 in patients treated with these regimens.
- Compare the quality of life changes in patients treated with these regimens.
- Identify factors predicting toxicity from capecitabine chemotherapy.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
stratified according to gender and treatment setting (adjuvant/neoadjuvant vs palliative
setting). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Beginning concurrently with planned capecitabine treatment, patients receive
oral pyridoxine hydrochloride once daily on days 1-21.
- Arm II: Beginning concurrently with planned capecitabine treatment, patients receive
oral placebo once daily on days 1-21.
In both arms, treatment repeats every 21 days for up to 8 courses (until discontinuation of
Quality of life is assessed at baseline, at the beginning of courses 2, 4, 6, and 8, and at
the end of the study.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
First incidence of hand-foot syndrome (HFS) ≥ grade 2 according to NCI CTCAE vs 3.0
up to 8 cycles
Yoon-Sim Yap, FRACP, MBBS
National Cancer Centre, Singapore
Singapore: Health Sciences Authority