Study of Pyridoxine for Hand-Foot Syndrome

NCT ID: NCT00446147

Last Updated: 2014-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 389 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2006-12-31

Brief 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.

Detailed Description

Although pyridoxine has been used empirically for the prevention of capecitabine associated HFS, its efficacy needs to be demonstrated in prospective controlled trials. We estimated that the HFS rate with placebo and pyridoxine would be 0.35 and 0.18, respectively, and we therefore calculated that a sample size of 345 patients would be necessary to detect these hazard rates with an 80% power (β=0.2) and two-sided significance level of α=0.05. We assumed a follow up loss rate of 10%, thus requiring 380 patients to be randomized. Chemotherapy-naive patients with gastrointestinal tract cancers who were scheduled for capecitabine-containing chemotherapy were assigned to receive oral pyridoxine or placebo in randomized double-blind placebo controlled study. Pyridoxine 100 mg b.i.d was prescribed to the patients in the pyridoxine group, identical placebo 100 mg b.i.d was prescribed in the placebo group by the closed envelop randomization. Patients were stratified by chemotherapy regimen: capecitabine alone (X), capecitabine and cisplatin (XP), or docetaxel, capecitabine, and cisplatin (DXP). Patients were observed until NCI CTC grade 2 or 3 HFS developed or capecitabine-containing chemotherapy ended. Patients in the placebo group who developed grade 2 or 3 HFS were randomized to receive pyridoxine or placebo for the next chemotherapy cycle to determine whether pyridoxine could improve HFS, and the same treatment was continued for 2 chemotherapy cycles.

Conditions

Hand-foot Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Placebo

one tablet twice per day, which is identical to pyridoxine

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo 100mg BID/daily, Per oral

Pyridoxine

100 mg twice per day

Group Type: EXPERIMENTAL

Pyridoxine

Intervention Type: DRUG

100mg BID/daily, Per oral

Interventions

Pyridoxine

100mg BID/daily, Per oral

Intervention Type: DRUG

Placebo

placebo 100mg BID/daily, Per oral

Intervention Type: DRUG

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 <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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Yoon-Koo Kang

Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yoon-Koo Kang

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center IRB

References

Kang YK, Lee SS, Yoon DH, Lee SY, Chun YJ, Kim MS, Ryu MH, Chang HM, Lee JL, Kim TW. Pyridoxine is not effective to prevent hand-foot syndrome associated with capecitabine therapy: results of a randomized, double-blind, placebo-controlled study. J Clin Oncol. 2010 Aug 20;28(24):3824-9. doi: 10.1200/JCO.2010.29.1807. Epub 2010 Jul 12.

Reference Type: DERIVED

PMID: 20625131 (View on PubMed)

Other Identifiers

AMC-ONCGI-0403

Identifier Type: -

Identifier Source: org_study_id