Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Capecitabine for Advanced Colorectal Cancer or Breast Cancer
- Conditions
- Colorectal CancerPalmar-plantar ErythrodysesthesiaBreast Cancer
- Registration Number
- NCT00559858
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
Primary
* Determine whether pyridoxine can reduce the incidence of capecitabine dose modifications (dose delay and dose reductions) due to toxicity.
Secondary
* 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 270
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of capecitabine dose modifications (dose delay and dose reductions) due to toxicity
- Secondary Outcome Measures
Name Time Method Measurement of biomarkers that might predict the occurrence of HFS Response to chemotherapy Progression-free survival Incidence of hand-foot syndrome (HFS) Quality of life Overall toxicity
Trial Locations
- Locations (16)
Addenbrooke's Hospital
🇬🇧Cambridge, England, United Kingdom
West Suffolk Hospital
🇬🇧Bury St. Edmunds, England, United Kingdom
Kent and Canterbury Hospital
🇬🇧Canterbury, England, United Kingdom
Royal Devon and Exeter Hospital
🇬🇧Exeter, England, United Kingdom
Southend University Hospital NHS Foundation Trust
🇬🇧Westcliff-On-Sea, England, United Kingdom
Great Western Hospital
🇬🇧Swindon, England, United Kingdom
Primrose Oncology Unit
🇬🇧Bedford, England, United Kingdom
Kent and Sussex Hospital
🇬🇧Tunbridge Wells, England, United Kingdom
Queen Elizabeth Hospital
🇬🇧King's Lynn, England, United Kingdom
Basildon University Hospital
🇬🇧Basildon, England, United Kingdom
Derbyshire Royal Infirmary
🇬🇧Derby, England, United Kingdom
Walsall Manor Hospital
🇬🇧Walsall, England, United Kingdom
Royal Albert Edward Infirmary
🇬🇧Lancanshire, England, United Kingdom
Derriford Hospital
🇬🇧Plymouth, England, United Kingdom
Mid Kent Oncology Centre at Maidstone Hospital
🇬🇧Maidstone, England, United Kingdom
Peterborough Hospitals Trust
🇬🇧Peterborough, England, United Kingdom