Pyridoxine and Topical Urea/Lactic Acid-Based Cream in Preventing Hand-Foot Syndrome in Patients Receiving Capecitabine for Breast Cancer or Other Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology; North Central Cancer Treatment Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Capecitabine; Pyridoxal; Pyridoxine; Vitamin B 6

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