Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Capecitabine for Advanced Colorectal Cancer or Breast Cancer
Recruitment status was Active, not recruiting
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.
Dietary Supplement: pyridoxine hydrochloride
Procedure: quality-of-life assessment
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|Official Title:||A Randomised Placebo-controlled Study Evaluating the Role of Pyridoxine in Controlling Capecitabine-induced Hand-foot Syndrome|
- 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
|Study Start Date:||December 2004|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
- 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.
|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|