Ota, M., Tatsumi, K., Suwa, H., Watanabe, J., Watanabe, K., Osada, S., . . . Endo, I. (2014). The effect of pyridoxine for prevention of hand-foot syndrome in colorectal cancer patients with adjuvant chemotherapy using capecitabine: A randomized study. Hepato-Gastroenterology, 61, 1008–1013. 

To assess the effectiveness of pyridoxine for the prevention of hand-foot syndrome in patients receiving capecitabine

Patients were randomized to receive pyridoxine or not. Pyridoxine 30 mg was given three times daily during chemotherapy. The primary study endpoint was hand-foot syndrome of grade 2 or higher.

• N = 60   
• MEAN AGE = 62.1 years
• MALES: Not provided, FEMALES: Not provided
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Colorectal cancer

• SITE: Multi-site   
• SETTING TYPE: Outpatient    
• LOCATION: Japan

PHASE OF CARE: Active antitumor treatment

Open-label, randomized, controlled trial

Common Terminology Criteria for Adverse Events (CTCAE)

Sixty percent of patients had at least grade 2 hand-foot syndrome. No differences existed between study groups.

Pyridoxine was not shown to have an effect for the prevention of hand-foot syndrome.

• Small sample (< 100)
• Risk of bias (no blinding)

Pyridoxine was not shown to have a preventive effect on the development of hand-foot syndrome. There are few interventions studied or shown to be effective for the prevention of this complication of cancer treatment. Ongoing research is needed to determine the effective approaches for the management of skin and nail toxicities.