Study of Pyridoxine for Hand-Foot Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00446147
Recruitment Status : Completed
First Posted : March 12, 2007
Results First Posted : February 25, 2014
Last Update Posted : February 25, 2014
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center

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.

Condition or disease Intervention/treatment Phase
Hand-foot Syndrome Drug: Pyridoxine Drug: Placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 389 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Double-Blind Phase III Study of Pyridoxine vs Placebo for the Prevention of Capecitabine-induced Hand-Foot Syndrome
Study Start Date : June 2004
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Placebo Comparator: Placebo
one tablet twice per day, which is identical to pyridoxine
Drug: Placebo
placebo 100mg BID/daily, Per oral

Experimental: Pyridoxine
100 mg twice per day
Drug: Pyridoxine
100mg BID/daily, Per oral

Primary Outcome Measures :
  1. Cumulative Dose of Capecitabine Until the Development of Grade 2 or Higher Hand-foot Syndrome [ Time Frame: Up to 2 years ]
    A total administered dose of capecitabine until the development of grade 2 or higher hand-foot syndrome during the chemotherapy.

Secondary Outcome Measures :
  1. Number of Patients With Hand-foot Syndrome [ Time Frame: Up to 2 years ]
    Number of patients with any grade of hand-foot syndrome

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00446147

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Yoon-Koo Kang, Oncologist, Asan Medical Center Identifier: NCT00446147     History of Changes
Other Study ID Numbers: AMC-ONCGI-0403
First Posted: March 12, 2007    Key Record Dates
Results First Posted: February 25, 2014
Last Update Posted: February 25, 2014
Last Verified: January 2014

Keywords provided by Yoon-Koo Kang, Asan Medical Center:
hand-foot syndrome

Additional relevant MeSH terms:
Hand-Foot Syndrome
Pathologic Processes
Drug Eruptions
Skin Diseases
Drug Hypersensitivity
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Vitamin B 6
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs