Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Capecitabine for Advanced Colorectal Cancer or Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00559858|
Recruitment Status : Unknown
Verified December 2008 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : November 16, 2007
Last Update Posted : August 2, 2013
RATIONALE: Pyridoxine (vitamin B6) may prevent or lessen hand-foot syndrome caused by chemotherapy. It is not yet known whether pyridoxine is more effective than a placebo in preventing hand-foot syndrome.
PURPOSE: This phase III randomized trial is studying pyridoxine to see how well it works compared to a placebo in preventing hand-foot syndrome in patients who are receiving capecitabine for advanced colorectal cancer or breast cancer.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Colorectal Cancer Palmar-plantar Erythrodysesthesia||Dietary Supplement: pyridoxine hydrochloride Other: placebo Procedure: quality-of-life assessment||Phase 3|
- Determine whether pyridoxine can reduce the incidence of capecitabine dose modifications (dose delay and dose reductions) due to toxicity.
- Determine the incidence of hand-foot syndrome (HFS).
- Determine the overall toxicity.
- Determine the quality of life.
- Determine the response to chemotherapy.
- Determine the progression-free survival.
- Determine the level of biomarkers which might predict the occurrence of HFS.
OUTLINE: This is a multicenter study. Patients are stratified according to disease (breast cancer vs colorectal cancer). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral pyridoxine hydrochloride 3 times daily beginning with the initiation of capecitabine chemotherapy and continuing until completion of chemotherapy.
- Arm II: Patients receive oral placebo 3 times daily beginning with the initiation of capecitabine chemotherapy and continuing until completion of chemotherapy.
In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.
Evidence of hand-foot syndrome is assessed at baseline and before each course of capecitabine. Quality of life is assessed at baseline and then every 6 weeks.
After completion of study treatment, patients are followed at 6 and 12 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||270 participants|
|Primary Purpose:||Supportive Care|
|Official Title:||A Randomised Placebo-controlled Study Evaluating the Role of Pyridoxine in Controlling Capecitabine-induced Hand-foot Syndrome|
|Study Start Date :||December 2004|
|Estimated Primary Completion Date :||December 2009|
- Incidence of capecitabine dose modifications (dose delay and dose reductions) due to toxicity
- Incidence of hand-foot syndrome (HFS)
- Overall toxicity
- Quality of life
- Response to chemotherapy
- Progression-free survival
- Measurement of biomarkers that might predict the occurrence of HFS
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00559858
|Basildon University Hospital|
|Basildon, England, United Kingdom, SS16 5NL|
|Primrose Oncology Unit|
|Bedford, England, United Kingdom, MK42 9DJ|
|West Suffolk Hospital|
|Bury St. Edmunds, England, United Kingdom, IP33 2QZ|
|Cambridge, England, United Kingdom, CB2 2QQ|
|Kent and Canterbury Hospital|
|Canterbury, England, United Kingdom, CT2 7NR|
|Derbyshire Royal Infirmary|
|Derby, England, United Kingdom, DE1 2QY|
|Royal Devon and Exeter Hospital|
|Exeter, England, United Kingdom, EX2 5DW|
|Queen Elizabeth Hospital|
|King's Lynn, England, United Kingdom, PE30 4ET|
|Royal Albert Edward Infirmary|
|Lancanshire, England, United Kingdom, WN1 2NN|
|Mid Kent Oncology Centre at Maidstone Hospital|
|Maidstone, England, United Kingdom, ME16 9QQ|
|Peterborough Hospitals Trust|
|Peterborough, England, United Kingdom, PE3 6DA|
|Plymouth, England, United Kingdom, PL6 8DH|
|Great Western Hospital|
|Swindon, England, United Kingdom, SN3 6BB|
|Kent and Sussex Hospital|
|Tunbridge Wells, England, United Kingdom, TN4 8AT|
|Walsall Manor Hospital|
|Walsall, England, United Kingdom, WS2 9PS|
|Southend University Hospital NHS Foundation Trust|
|Westcliff-On-Sea, England, United Kingdom, SS0 0RY|
|Study Chair:||Pippa Corrie, PhD, FRCP||Cambridge University Hospitals NHS Foundation Trust|