NCT00296036

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVES: * Determine whether the prophylactic use of a topical urea/lactic acid cream can decrease the incidence/severity of capecitabine-caused palmar-plantar erythrodysesthesia in patients receiving capecitabine for breast and/or other cancer. * Evaluate the potential toxicity of this cream. * Determine whether the prophylactic use of vitamin B6 can decrease the incidence and/or severity of capecitabine-caused palmar-plantar erythrodysesthesia. * Evaluate the potential toxicity of vitamin B6. * 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. OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to age (\< 50 years old vs 50-60 years old vs \> 60 years old), sex, capecitabine dose level (2000 mg/day vs 2500 mg/day), cancer type (breast vs other), and mode of therapy (adjuvant \[including neo-adjuvant\] therapy vs metastatic disease). Patients are randomized to 1 of 6 treatment arms (treatment arms I-IV closed to accrual as of 10/24/007). * Arm I (closed to accrual as of 10/24/2007): Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily and oral pyridoxine once daily on days 1-21. * Arm II (closed to accrual as of 10/24/2007): 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. * Arm III (closed to accrual as of 10/24/2007): Patients receive placebo cream applied to palms and soles twice daily and pyridoxine as in arm I (closed to accrual as of 10/24/2007). * Arm IV (closed to accrual as of 10/24/2007):Patients receive placebo cream as in arm III and oral placebo as in arm II (closed to accrual as of 10/24/2007). * Arm V: Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily on days 1-21. * Arm VI: Patients receive placebo cream applied to palms and soles twice daily on days 1-21. In all arms, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Conditions

• Breast Cancer
• Drug/Agent Toxicity by Tissue/Organ
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	pyridoxine hydrochloride	Given orally
DRUG	urea/lactic acid-based topical cream	Applied topically
OTHER	placebo	Given orally or applied topically

Timeline

• Start date: 2006-06-01
• Primary completion: 2009-07-01
• First posted: 2006-02-24
• Last updated: 2017-03-16
• Results posted: 2017-03-16

Locations

231 sites across 1 country: United States