Clinical trial · Interventional
Pyridoxine and Topical Urea/Lactic Acid-Based Cream in Preventing Hand-Foot Syndrome in Patients Receiving Capecitabine for Breast Cancer or Other Cancer
A Phase III Randomized, Placebo-controlled, Double-blind Trial to Determine the Effectiveness of a Urea/Lactic Acid-Based Topical Keratolytic Agent and Vitamin B-6 for Prevention of Capecitabine-Induced Hand and 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) and topical urea/lactic acid-based cream may prevent or lessen hand-foot syndrome caused by chemotherapy. It is not yet known whether giving pyridoxine with or without topical urea/lactic acid-based cream is more effective than topical urea/lactic acid-based cream alone or a placebo in preventing hand-foot syndrome. PURPOSE: This randomized phase III trial is studying pyridoxine and topical urea/lactic acid-based cream to see how well they work compared with giving pyridoxine together with a placebo, giving topical urea/lactic acid-based cream together with a placebo, or giving two placebos in preventing hand-foot syndrome in patients who are receiving capecitabine for breast cancer or other 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 |
| Drug/Agent Toxicity by Tissue/Organ | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| placebo | Other | — | UNRESOLVED |
| pyridoxine hydrochloride | Dietary Supplement | — | UNRESOLVED |
| urea/lactic acid-based topical cream | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Arm I (closed to accrual as of 10/24/2007)
- description
- Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily and oral pyridoxine once daily on days 1-21.
- interventionNames
- Dietary Supplement: pyridoxine hydrochloride
- Drug: urea/lactic acid-based topical cream
- type
- EXPERIMENTAL
- label
- Arm II (closed to accrual as of 10/24/2007)
- description
- Patients receive topical urea/lactic acid-based cream as in arm I (closed to accrual as of 10/24/2007) and oral placebo once daily on days 1-21.
- interventionNames
- Drug: urea/lactic acid-based topical cream
- Other: placebo
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed breast and/or other cancer * Undergoing first treatment with capecitabine as adjuvant (including neo-adjuvant) therapy OR for metastatic disease * Receiving a dose of capecitabine either 2,000 mg/day (1,000 mg twice daily) OR 2,500 mg/day for 14 days with 4 courses of therapy at 3 week (+/- 3 days) intervals * Hormone-receptor status not specified PATIENT CHARACTERISTICS: * Male or female * Menopausal status not specified * No history of allergy to urea-containing cream * No pre-existing neuropathy ≥ grade 2 * 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: * No other concurrent agents that function to prevent palmar-plantar erythrodysesthesia caused by capecitabine or topical agents in the hands or feet for other indications (e.g., dryness) * No concurrent vitamin B6 \> 50 mg/day * No concurrent or planned use of over-the-counter products that contain urea or lactic acid, including any of the following: * Aqua Care® * Medicated Calamine\^® lotion (0.3%) * Coppertone\^® Waterproof Ultra Protection Sunblock * Dr. Scholl's\^® Smooth Touch deep moisturizing cream * Depicure\^® So Smooth Cream * Dove\^® Moisturizing Cream Wash * Cetaphil\^ ®Moisturizing Cream * Vaseline Intensive Care \^ ® lotion
References
Publications (1)
- RESULTWolf SL, Qin R, Menon SP, Rowland KM Jr, Thomas S, Delaune R, Christian D, Pajon ER Jr, Satele DV, Berenberg JL, Loprinzi CL; North Central Cancer Treatment Group Study N05C5. Placebo-controlled trial to determine the effectiveness of a urea/lactic acid-based topical keratolytic agent for prevention of capecitabine-induced hand-foot syndrome: North Central Cancer Treatment Group Study N05C5. J Clin Oncol. 2010 Dec 10;28(35):5182-7. doi: 10.1200/JCO.2010.31.1431. Epub 2010 Nov 8. PMID 21060036