Clinical trial · Interventional
Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Capecitabine for Advanced Colorectal Cancer or Breast Cancer
A Randomised Placebo-controlled Study Evaluating the Role of Pyridoxine in Controlling Capecitabine-induced Hand-foot Syndrome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Palmar-plantar Erythrodysesthesia | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| placebo | Other | — | UNRESOLVED |
| pyridoxine hydrochloride | Dietary Supplement | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Incidence of capecitabine dose modifications (dose delay and dose reductions) due to toxicity
Secondary outcomes (6)
- measure
- Incidence of hand-foot syndrome (HFS)
- measure
- Overall toxicity
- measure
- Quality of life
- measure
- Response to chemotherapy
- measure
- Progression-free survival
- measure
- Measurement of biomarkers that might predict the occurrence of HFS
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available