Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Capecitabine for Advanc… (NCT00559858) | Clinical Trial Compass
UnknownPhase 3
Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Capecitabine for Advanced Colorectal Cancer or Breast Cancer
United Kingdom270 participantsStarted 2004-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Diagnosis of advanced colorectal or breast carcinoma
* Hormone receptor status not specified
* Receiving single-agent capecitabine chemotherapy
* Measurable disease for response assessment, determined on an individual patient basis, using conventional clinical and/or radiological methods
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Menopausal status not specified
* Life expectancy ≥ 12 weeks
* Hemoglobin ≥ 10 g/dL
* Platelet count ≥ 100,000 mm\^3
* WBC ≥ 3,000/mm\^3
* ANC ≥ 1,500/mm\^3
* Bilirubin ≤ 1.3 x upper limit of normal (ULN)
* Alkaline phosphatase ≤ 5 x ULN
* AST and ALT ≤ 5 x ULN
* Creatinine ≤ 1.5 x ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after completion of study treatment
* No other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial
* No medical or psychiatric condition which would influence the ability to provide informed consent
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 6 weeks since prior investigational agents
* Concurrent radiotherapy allowed
* No other concurrent chemotherapy or immunotherapy
* No concurrent nonsteroidal anti-inflammatory drugs NSAIDs) for the primary purpose of treating hand-foot syndrome (HFS) or cancer
* NSAIDs for conditions other than HFS or cancer allowed
What they're measuring
1
Incidence of capecitabine dose modifications (dose delay and dose reductions) due to toxicity
Trial details
NCT IDNCT00559858
SponsorCambridge University Hospitals NHS Foundation Trust