- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00446147
Study of Pyridoxine for Hand-Foot Syndrome
January 13, 2014 updated by: Yoon-Koo Kang, Asan Medical Center
Double-Blind Phase III Study of Pyridoxine vs Placebo for the Prevention of Capecitabine-induced Hand-Foot Syndrome
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
389
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
one tablet twice per day, which is identical to pyridoxine
|
placebo 100mg BID/daily, Per oral
|
Experimental: Pyridoxine
100 mg twice per day
|
100mg BID/daily, Per oral
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients With Hand-foot Syndrome
Time Frame: Up to 2 years
|
Number of patients with any grade of hand-foot syndrome
|
Up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yoon-Koo Kang, Asan Medical Center IRB
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2004
Primary Completion (Actual)
December 1, 2006
Study Completion (Actual)
December 1, 2006
Study Registration Dates
First Submitted
March 9, 2007
First Submitted That Met QC Criteria
March 9, 2007
First Posted (Estimate)
March 12, 2007
Study Record Updates
Last Update Posted (Estimate)
February 25, 2014
Last Update Submitted That Met QC Criteria
January 13, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AMC-ONCGI-0403
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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