NCT00446147

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
389

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2004

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2007

Completed
7 years until next milestone

Results Posted

Study results publicly available

February 25, 2014

Completed
Last Updated

February 25, 2014

Status Verified

January 1, 2014

Enrollment Period

2.5 years

First QC Date

March 9, 2007

Results QC Date

January 13, 2014

Last Update Submit

January 13, 2014

Conditions

Hand-foot Syndrome

Keywords

hand-foot syndromecapecitabinepyridoxineprevention

Outcome Measures

Primary Outcomes (1)

  • Cumulative Dose of Capecitabine Until the Development of Grade 2 or Higher Hand-foot Syndrome

    A total administered dose of capecitabine until the development of grade 2 or higher hand-foot syndrome during the chemotherapy.

    Up to 2 years

Secondary Outcomes (1)

  • Number of Patients With Hand-foot Syndrome

    Up to 2 years

Study Arms (2)

Placebo

PLACEBO COMPARATOR

one tablet twice per day, which is identical to pyridoxine

Drug: Placebo

Pyridoxine

EXPERIMENTAL

100 mg twice per day

Drug: Pyridoxine

Interventions

PyridoxineDRUG

100mg BID/daily, Per oral

Pyridoxine
PlaceboDRUG

placebo 100mg BID/daily, Per oral

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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/㎗).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 20625131DERIVED

MeSH Terms

Conditions

Hand-Foot Syndrome

Interventions

Pyridoxine

Condition Hierarchy (Ancestors)

Drug EruptionsDermatitisSkin DiseasesSkin and Connective Tissue DiseasesDrug HypersensitivityDrug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Vitamin B 6PicolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. Yoon-Koo Kang
Organization
Asan Medical Center
ykkang@amc.seoul.kr
+82-2-3010-3210

Study Officials

  • Yoon-Koo Kang

    Asan Medical Center IRB

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Oncologist

Study Record Dates

First Submitted

March 9, 2007

First Posted

March 12, 2007

Study Start

June 1, 2004

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

February 25, 2014

Results First Posted

February 25, 2014

Record last verified: 2014-01