- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00767689
Vitamin B6 Can Prevent Hand and Foot Syndrome in Cancer Patients Capecitabine Chemotherapy
June 13, 2023 updated by: Pamela Gonzalez Sr Director Clinical Research Office, Cook County Health
A Randomized Trial to Determine if Vitamin B6 Can Prevent Hand and Foot Syndrome in Cancer Patients Treated With Capecitabine Chemotherapy
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tareq Braik, MD
- Phone Number: 312-8390060
- Email: tareqbk410@hotmail.com
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- John H Stroger Jr Hospital of Cook County
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: vitamin B6
patient receiving xeloda and vitamin B6
|
vitamin b6 100 mg po daily
Other Names:
|
Placebo Comparator: 2 placebo
patient receiving xeloda and placebo
|
placebo is given in the placebo arm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Hand-Foot Syndrome (HFS)
Time Frame: 1 year
|
Incidence of HFS based on CTCTAE adverse event table
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Grade of Hand-Foot Syndrome (HFS)
Time Frame: 1 year
|
Grading of HFS: Grade 1, Grade 2, Grade 3 per NCI CTCTAE V 3
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Thomas Lad, MD, Cook County Health Oncology NCORP
- Principal Investigator: Susan McDunn, MD, Cook County Health
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 (Actual)
March 21, 2006
Primary Completion (Actual)
March 18, 2009
Study Completion (Actual)
March 17, 2010
Study Registration Dates
First Submitted
October 6, 2008
First Submitted That Met QC Criteria
October 6, 2008
First Posted (Estimated)
October 7, 2008
Study Record Updates
Last Update Posted (Actual)
June 15, 2023
Last Update Submitted That Met QC Criteria
June 13, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Pathologic Processes
- Skin Diseases
- Disease
- Dermatitis
- Drug-Related Side Effects and Adverse Reactions
- Drug Eruptions
- Drug Hypersensitivity
- Syndrome
- Hand-Foot Syndrome
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Vitamin B Complex
- Vitamin B 6
- Pyridoxal
- Pyridoxine
Other Study ID Numbers
- 08-069
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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Heinrich-Heine University, DuesseldorfTerminatedThe Effect of Topical Brimonidine Tartrate on Hand-foot Syndrome (HFS) in Cancer Patients (BRIMOCAN)Hand-foot SyndromeGermany
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