NCT00925418

Evaluation of the Cryotherapy in the Prevention of Nails Toxicity Induced by Taxotere® in Breast or Prostate Cancer

Randomized Trial Evaluating the Cryotherapy in the Prevention of Nails Toxicity Induced by Taxotere® in Patient Treated for Breast or Prostate Cancer.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: Institut Paoli-Calmettes · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Taxotere® can induce nails changes like dyschromia, hematoma, lines of Beau-Reil (signing the stop of the epithelial proliferation), abscess, or pain. In this context, this randomized, monocentric phase III trial evaluates the cryotherapy, using frozen glove, in the prevention of nails toxicity induced by Taxotere® in patient treated for breast or prostate cancer. Primary objective: Demonstrate a reduction of the nails toxicity using frozen glove during chemotherapy with Taxotere®. Secondary objectives: Analysis of time of protection against onycholysis Estimation of the efficiency of cryotherapy, and impact on quality of life Tolerance and compliance of the frozen glove

Conditions

• Breast Neoplasms
• Prostate Cancer
• Nail Diseases

Interventions

Type	Name	Description
PROCEDURE	Frozen Glove	Using frozen glove during chemotherapy with Taxotere®

Timeline

• Start date: 2006-09-01
• Primary completion: 2010-09-01
• Completion: 2011-07-01
• First posted: 2009-06-22
• Last updated: 2011-09-14

Locations

1 site across 1 country: France