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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo

one tablet twice per day, which is identical to pyridoxine

Placebo: placebo 100mg BID/daily, Per oral

Pyridoxine

100 mg twice per day

Pyridoxine: 100mg BID/daily, Per oral


Participant Flow:   Overall Study
    Placebo   Pyridoxine
STARTED   195   194 
COMPLETED   180   180 
NOT COMPLETED   15   14 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo

one tablet twice per day, which is identical to pyridoxine

Placebo: placebo 100mg BID/daily, Per oral

Pyridoxine

100 mg twice per day

Pyridoxine: 100mg BID/daily, Per oral

Total Total of all reporting groups

Baseline Measures
   Placebo   Pyridoxine   Total 
Overall Participants Analyzed 
[Units: Participants]
 180   180   360 
Age, Customized 
[Units: Years]
Median (Full Range)
     
Age_median   56 
 (28 to 74) 
 56 
 (20 to 75) 
 56 
 (20 to 75) 
Gender 
[Units: Participants]
     
Female   76   59   135 
Male   104   121   225 
Region of Enrollment 
[Units: Participants]
     
Korea, Republic of   180   180   360 


  Outcome Measures

1.  Primary:   Cumulative Dose of Capecitabine Until the Development of Grade 2 or Higher Hand-foot Syndrome   [ Time Frame: Up to 2 years ]

2.  Secondary:   Number of Patients With Hand-foot Syndrome   [ Time Frame: Up to 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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
e-mail: ykkang@amc.seoul.kr


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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