Phase 3
N=137
Pyridoxine and Topical Urea/Lactic Acid-Based Cream in Preventing Hand-Foot Syndrome in Patients Receiving Capecitabine for Breast Cancer or Other Cancer
Breast Cancer · Drug/Agent Toxicity by Tissue/Organ · Unspecified Adult Solid Tumor, Protocol Specific
Bottom Line
View on ClinicalTrials.gov: NCT00296036 ↗Enrolled (actual)
137
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: To Determine Whether the Prophylactic Use of a Topical Urea/Lactic Acid Cream Can Decrease the Incidence/Severity of Capecitabine-caused Palmar-plantar Erythrodysesthesia — 13.6; 10.2 percentage of participants — p=0.768
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- pyridoxine hydrochloride (Dietary_supplement); urea/lactic acid-based topical cream (Drug); placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alliance for Clinical Trials in Oncology
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Determine Whether the Prophylactic Use of a Topical Urea/Lactic Acid Cream Can Decrease the Incidence/Severity of Capecitabine-caused Palmar-plantar Erythrodysesthesia |
13.6; 10.2 | 0.768 |
| SECONDARY To Evaluate the Potential Toxicity of Urea/Lactic Acid Cream |
21; 18; 3; 3 | — |
| SECONDARY Determine Whether the Prophylactic Use of Vitamin B6 Can Decrease the Incidence and/or Severity of Capecitabine-caused Palmar-plantar Erythrodysesthesia (HFSD). |
— | — |
| SECONDARY Evaluate the Potential Toxicity of Vitamin B6. |
— | — |
| SECONDARY Determine Whether the Prophylactic Use of a Topical Urea/Lactic Acid Cream in Combination With Vitamin B6 Can Decrease the Incidence and/or Severity of Capecitabine Caused Palmar-plantar Erythrodysesthesia. |
— | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00296036). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.