Study of Pyridoxine for Hand-Foot Syndrome

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Although pyridoxine has been used empirically for the prevention of capecitabine associated hand-foot syndrome (HFS), its efficacy needs to be demonstrated in prospective controlled trials. The investigators therefore performed a prospective randomized double-blind study to determine whether pyridoxine 200 mg/day can prevent the development of HFS when given concurrently with capecitabine. The investigators also tested the ability of pyridoxine to treat primary occurrence of grade 2-3 HFS.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Asan Medical Center
• Treatments: Capecitabine; Pyridoxal; Pyridoxine; Vitamin B 6

Criteria

Inclusion Criteria:

• Gastrointestinal tract cancer patients treated with capecitabine-containing chemotherapy as a first-line treatment were randomly allocated to concurrent treatment with pyridoxine or placebo.

• All patients were 18 to 70 years old

• Had Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower

• An estimated life expectancy > 3 months

• Adequate bone marrow function, including white blood cell (WBC) count of >3500 cells/㎕ and platelet count of >100000/㎕

• Adequate renal function (serum creatinine concentration <1.5 mg/㎗)

• Adequate liver function with (serum bilirubin concentration <1.5 mg/㎗, transaminase <3 times the upper normal limit, and serum albumin >2.5 mg/㎗).

Exclusion Criteria:

• Previous treatment for HFS

• Hypersensitivity to pyridoxine

• A combination of other malignancies

• Serious illnesses or medical conditions

• Immune suppression or positive human immunodeficiency virus (HIV) serology

• Pregnant or lactating women.