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Study of Pyridoxine for Hand-Foot Syndrome

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ClinicalTrials.gov Identifier: NCT00446147
Recruitment Status : Completed
First Posted : March 12, 2007
Results First Posted : February 25, 2014
Last Update Posted : February 25, 2014
Sponsor:
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Hand-foot Syndrome
Interventions Drug: Pyridoxine
Drug: Placebo
Enrollment 389
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Pyridoxine
Hide Arm/Group Description

one tablet twice per day, which is identical to pyridoxine

Placebo: placebo 100mg BID/daily, Per oral

100 mg twice per day

Pyridoxine: 100mg BID/daily, Per oral

Period Title: Overall Study
Started 195 194
Completed 180 180
Not Completed 15 14
Arm/Group Title Placebo Pyridoxine Total
Hide Arm/Group Description

one tablet twice per day, which is identical to pyridoxine

Placebo: placebo 100mg BID/daily, Per oral

100 mg twice per day

Pyridoxine: 100mg BID/daily, Per oral

Total of all reporting groups
Overall Number of Baseline Participants 180 180 360
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Median (Full Range)
Unit of measure:  Years
Age_median Number Analyzed 180 participants 180 participants 360 participants
56
(28 to 74)
56
(20 to 75)
56
(20 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 180 participants 360 participants
Female
76
  42.2%
59
  32.8%
135
  37.5%
Male
104
  57.8%
121
  67.2%
225
  62.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 180 participants 180 participants 360 participants
180 180 360
1.Primary Outcome
Title Cumulative Dose of Capecitabine Until the Development of Grade 2 or Higher Hand-foot Syndrome
Hide Description A total administered dose of capecitabine until the development of grade 2 or higher hand-foot syndrome during the chemotherapy.
Time Frame Up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Pyridoxine
Hide Arm/Group Description:

one tablet twice per day, which is identical to pyridoxine

Placebo: placebo 100mg BID/daily, Per oral

100 mg twice per day

Pyridoxine: 100mg BID/daily, Per oral

Overall Number of Participants Analyzed 180 180
Median (95% Confidence Interval)
Unit of Measure: miligram per square meter
70000
(69384 to 70615)
70000
(60010 to 79989)
2.Secondary Outcome
Title Number of Patients With Hand-foot Syndrome
Hide Description Number of patients with any grade of hand-foot syndrome
Time Frame Up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Pyridoxine
Hide Arm/Group Description:

one tablet twice per day, which is identical to pyridoxine

Placebo: placebo 100mg BID/daily, Per oral

100 mg twice per day

Pyridoxine: 100mg BID/daily, Per oral

Overall Number of Participants Analyzed 180 180
Measure Type: Number
Unit of Measure: participants
55 57
Time Frame Up to 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Pyridoxine
Hide Arm/Group Description

one tablet twice per day, which is identical to pyridoxine

Placebo: placebo 100mg BID/daily, Per oral

100 mg twice per day

Pyridoxine: 100mg BID/daily, Per oral

All-Cause Mortality
Placebo Pyridoxine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Pyridoxine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/180 (0.00%)   0/180 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Pyridoxine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/180 (0.00%)   0/180 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Yoon-Koo Kang
Organization: Asan Medical Center
Phone: +82-2-3010-3210
Responsible Party: Yoon-Koo Kang, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00446147     History of Changes
Other Study ID Numbers: AMC-ONCGI-0403
First Submitted: March 9, 2007
First Posted: March 12, 2007
Results First Submitted: January 13, 2014
Results First Posted: February 25, 2014
Last Update Posted: February 25, 2014