Clinical trial · Interventional
Pyridoxine in Preventing Hand-Foot Syndrome Caused by Capecitabine in Patients With Cancer
Randomized Double-Blind Placebo-Controlled Trial of Pyridoxine for Prevention of Capecitabine-Induced Hand-Foot Syndrome (HFS)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
RATIONALE: Pyridoxine may help prevent hand-foot syndrome caused by capecitabine in patients with cancer. It is not yet known whether pyridoxine is more effective than a placebo in preventing hand-foot syndrome in patients with cancer. PURPOSE: This randomized phase III trial is studying pyridoxine to see how well it works compared with a placebo in preventing hand-foot syndrome caused by capecitabine in patients with 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 |
|---|---|---|---|
| Dermatologic Complications | — | UNRESOLVED | — |
| Palmar-plantar Erythrodysesthesia | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Other | — | UNRESOLVED |
| pyridoxine hydrochloride | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Pyridoxine hydrochloride
- description
- Pyridoxine (200mg) or placebo once daily orally for 21 days out of each treatment cycle
- interventionNames
- Dietary Supplement: pyridoxine hydrochloride
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Pyridoxine (200mg) or placebo once daily orally for 21 days out of each treatment cycle
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- First incidence of hand-foot syndrome (HFS) ≥ grade 2 according to NCI CTCAE vs 3.0
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of cancer * Must be receiving single-agent capecitabine either in the adjuvant/neoadjuvant or palliative setting at a dose of ≥ 1000 mg/m² twice daily on days 1-14 (given in 3-week courses) PATIENT CHARACTERISTICS: * Life expectancy \> 12 weeks * No preexisting neuropathy * No known allergy to pyridoxine hydrochloride and its incipients * No other dermatologic condition that, in the opinion of the physician, may affect the hands or feet or may complicate evaluation during study treatment PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior capecitabine * Concurrent radiotherapy, steroids, and/or biological therapy (e.g., trastuzumab \[Herceptin®\] or bevacizumab) allowed provided they do not cause hand-foot syndrome (HFS) * No other concurrent drugs (e.g., docetaxel or doxorubicin hydrochloride liposome) that can cause HFS * No concurrent drugs (e.g., oxaliplatin or taxanes) that can cause neuropathy * No concurrent pyridoxine hydrochloride-containing preparations (e.g., multivitamins or vitamin B complex) * No concurrent over-the-counter products that contain urea or lactic acid * No concurrent drugs reported to have drug interactions with pyridoxine hydrochloride (e.g., cycloserine; hydralazine; immunosuppressants; isoniazid; levodopa; estrogen or estrogen-containing contraceptives; penicillamine; phenobarbitone; phenytoin; or pyrazinamide)
References
Publications (1)
- DERIVEDYap YS, Kwok LL, Syn N, Chay WY, Chia JWK, Tham CK, Wong NS, Lo SK, Dent RA, Tan S, Mok ZY, Koh KX, Toh HC, Koo WH, Loh M, Ng RCH, Choo SP, Soong RCT. Predictors of Hand-Foot Syndrome and Pyridoxine for Prevention of Capecitabine-Induced Hand-Foot Syndrome: A Randomized Clinical Trial. JAMA Oncol. 2017 Nov 1;3(11):1538-1545. doi: 10.1001/jamaoncol.2017.1269. PMID 28715540