Vitamin B6 Can Prevent Hand and Foot Syndrome in Cancer Patients Capecitabine Chemotherapy
Primary Purpose
Hand and Foot Syndrome
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin B 6
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Hand and Foot Syndrome
Eligibility Criteria
Inclusion Criteria:
- Any adult patient starting capecitabine-containing chemotherapy
- Has never had capecitabine before
- Performance status 0-2 using the ECOG classification
- Life expectancy more than 6 months
- Agreed to stop any vitamin supplements, apart from vitamin D.
- Liver function studies including AST/ALT within 3x upper limit of normal
- Signed informed consent must be obtained from participating individuals
Sites / Locations
- John H stroger Jr hospital of cook county
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
vitamin B6
2 placebo
Arm Description
patient receiving xeloda and vitamin B6
patient receiving xeloda and placebo
Outcomes
Primary Outcome Measures
Incidence of Hand-Foot Syndrome (HFS)
Incidence of HFS based on CTCTAE adverse event table
Secondary Outcome Measures
Grade of Hand-Foot Syndrome (HFS)
Grading of HFS: Grade 1, Grade 2, Grade 3 per NCI CTCTAE V 3
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00767689
Brief Title
Vitamin B6 Can Prevent Hand and Foot Syndrome in Cancer Patients Capecitabine Chemotherapy
Official Title
A Randomized Trial to Determine if Vitamin B6 Can Prevent Hand and Foot Syndrome in Cancer Patients Treated With Capecitabine Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
incomplete enrollment
Study Start Date
March 21, 2006 (Actual)
Primary Completion Date
March 18, 2009 (Actual)
Study Completion Date
March 17, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cook County Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Capecitabine (Xeloda) a drug in cancer therapy. Its use is limited often by its toxicities. This study is asking if vitamin B6 can prevent one of the common toxicities of xeloda which is numbness and/or rash of the hands and feet, a condition called Hand and Foot syndrome. patients , starting capecitabine chemotherapy for their cancer, will participate in this study at John H. Stroger Jr. Hospital of Cook County. They will be randomized to receive either vitamin B6 or a placebo. investigators and patients will be blinded to the intervention.
Detailed Description
Double-blind, placebo-controlled trial, with randomly assignment of eligible patients who were treated with capecitabine to receive either daily pyridoxine 100 mg or placebo along with their capecitabine-containing chemotherapy regimen. Patients were observed during the first 4 cycles of capecitabine treatment. The primary endpoint was the incidence and grade of Hand-Foot Syndrome (HFS) that occurred in both study arms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand and Foot Syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vitamin B6
Arm Type
Experimental
Arm Description
patient receiving xeloda and vitamin B6
Arm Title
2 placebo
Arm Type
Placebo Comparator
Arm Description
patient receiving xeloda and placebo
Intervention Type
Drug
Intervention Name(s)
Vitamin B 6
Other Intervention Name(s)
pyridoxine
Intervention Description
vitamin b6 100 mg po daily
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo is given in the placebo arm
Primary Outcome Measure Information:
Title
Incidence of Hand-Foot Syndrome (HFS)
Description
Incidence of HFS based on CTCTAE adverse event table
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Grade of Hand-Foot Syndrome (HFS)
Description
Grading of HFS: Grade 1, Grade 2, Grade 3 per NCI CTCTAE V 3
Time Frame
1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Any adult patient starting capecitabine-containing chemotherapy
Has never had capecitabine before
Performance status 0-2 using the ECOG classification
Life expectancy more than 6 months
Agreed to stop any vitamin supplements, apart from vitamin D.
Liver function studies including AST/ALT within 3x upper limit of normal
Signed informed consent must be obtained from participating individuals
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Lad, MD
Organizational Affiliation
Cook County Health Oncology NCORP
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Susan McDunn, MD
Organizational Affiliation
Cook County Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
John H stroger Jr hospital of cook county
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Vitamin B6 Can Prevent Hand and Foot Syndrome in Cancer Patients Capecitabine Chemotherapy
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