Study of Pyridoxine for Hand-Foot Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00446147
First received: March 9, 2007
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Hand-foot Syndrome
Drug: Pyridoxine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Double-Blind Phase III Study of Pyridoxine vs Placebo for the Prevention of Capecitabine-induced Hand-Foot Syndrome

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Cumulative Dose of Capecitabine Until the Development of Grade 2 or Higher Hand-foot Syndrome [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    A total administered dose of capecitabine until the development of grade 2 or higher hand-foot syndrome during the chemotherapy.


Secondary Outcome Measures:
  • Number of Patients With Hand-foot Syndrome [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Number of patients with any grade of hand-foot syndrome


Enrollment: 389
Study Start Date: June 2004
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
one tablet twice per day, which is identical to pyridoxine
Drug: Placebo
placebo 100mg BID/daily, Per oral
Other Name: Placebo
Experimental: Pyridoxine
100 mg twice per day
Drug: Pyridoxine
100mg BID/daily, Per oral
Other Name: Pyridoxine

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00446147

Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Yoon-Koo Kang Asan Medical Center IRB
  More Information

No publications provided by Asan Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yoon-Koo Kang, Oncologist, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00446147     History of Changes
Other Study ID Numbers: AMC-ONCGI-0403
Study First Received: March 9, 2007
Results First Received: January 13, 2014
Last Updated: January 13, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:
hand-foot syndrome
capecitabine
pyridoxine
prevention

Additional relevant MeSH terms:
Hand-Foot Syndrome
Syndrome
Chemically-Induced Disorders
Dermatitis
Disease
Drug Eruptions
Drug Hypersensitivity
Drug-Related Side Effects and Adverse Reactions
Pathologic Processes
Skin Diseases
Pyridoxal
Pyridoxine
Vitamin B 6
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on October 20, 2014