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 range
18 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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