Clinical trial

Pyridoxine and Topical Urea/Lactic Acid-Based Cream in Preventing Hand-Foot…

NCT00296036 · Alliance for Clinical Trials in Oncology, Other · Completed

Key facts

NCT number NCT00296036
Title Pyridoxine and Topical Urea/Lactic Acid-Based Cream in Preventing Hand-Foot Syndrome in Patients Receiving Capecitabine for Breast Cancer or Other Cancer
Official title 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
Lead sponsor Alliance for Clinical Trials in Oncology, Other
Collaborators National Cancer Institute (NCI) NIH
Status Completed
Phase Phase 3
Study type Interventional
Conditions Breast Cancer, Drug/Agent Toxicity by Tissue/Organ, Unspecified Adult Solid Tumor, Protocol Specific
Intervention type Dietary Supplement, Drug, Other
Interventions pyridoxine hydrochloride, urea/lactic acid-based topical cream, placebo
Enrollment 137
Start date Jun 1, 2006
Primary completion Jul 1, 2009
First posted Feb 24, 2006
Last update posted Mar 16, 2017
Countries United States

At a glance

  • 100–999 Study sites
  • Yes Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date:

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