Study of Pyridoxine for Hand-Foot Syndrome
Primary Purpose
Hand-foot Syndrome
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Pyridoxine
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Hand-foot Syndrome focused on measuring hand-foot syndrome, capecitabine, pyridoxine, prevention
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Pyridoxine
Arm Description
one tablet twice per day, which is identical to pyridoxine
100 mg twice per day
Outcomes
Primary Outcome Measures
Cumulative Dose of Capecitabine Until the Development of Grade 2 or Higher Hand-foot Syndrome
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
Number of patients with any grade of hand-foot syndrome
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00446147
Brief Title
Study of Pyridoxine for Hand-Foot Syndrome
Official Title
Double-Blind Phase III Study of Pyridoxine vs Placebo for the Prevention of Capecitabine-induced Hand-Foot Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand-foot Syndrome
Keywords
hand-foot syndrome, capecitabine, pyridoxine, prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
389 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
one tablet twice per day, which is identical to pyridoxine
Arm Title
Pyridoxine
Arm Type
Experimental
Arm Description
100 mg twice per day
Intervention Type
Drug
Intervention Name(s)
Pyridoxine
Intervention Description
100mg BID/daily, Per oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo 100mg BID/daily, Per oral
Primary Outcome Measure Information:
Title
Cumulative Dose of Capecitabine Until the Development of Grade 2 or Higher Hand-foot Syndrome
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
Secondary Outcome Measure Information:
Title
Number of Patients With Hand-foot Syndrome
Description
Number of patients with any grade of hand-foot syndrome
Time Frame
Up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoon-Koo Kang
Organizational Affiliation
Asan Medical Center IRB
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
20625131
Citation
Kang YK, Lee SS, Yoon DH, Lee SY, Chun YJ, Kim MS, Ryu MH, Chang HM, Lee JL, Kim TW. Pyridoxine is not effective to prevent hand-foot syndrome associated with capecitabine therapy: results of a randomized, double-blind, placebo-controlled study. J Clin Oncol. 2010 Aug 20;28(24):3824-9. doi: 10.1200/JCO.2010.29.1807. Epub 2010 Jul 12.
Results Reference
derived
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Study of Pyridoxine for Hand-Foot Syndrome
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