Phase 3
N=389
Study of Pyridoxine for Hand-Foot Syndrome
Hand-foot Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00446147 ↗Enrolled (actual)
389
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: Cumulative Dose of Capecitabine Until the Development of Grade 2 or Higher Hand-foot Syndrome — 70000; 70000 miligram per square meter
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pyridoxine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Asan Medical Center
- Primary completion
- Dec 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Dose of Capecitabine Until the Development of Grade 2 or Higher Hand-foot Syndrome |
70000; 70000 | — |
| SECONDARY Number of Patients With Hand-foot Syndrome |
55; 57 | — |
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.
Eligibility 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 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.
Data sourced from ClinicalTrials.gov (NCT00446147). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.