Clinical Trial: Evaluation of the Cryotherapy in the Prevention of Nails Toxicity Induced by Taxotere® in Breast or Prostate Cancer
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Randomized Trial Evaluating the Cryotherapy in the Prevention of Nails Toxicity Induced by Taxotere® in Patient Treated for Breast or Prostate Cancer.
Brief 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
Detailed Summary:
Sponsor: Institut Paoli-Calmettes
Current Primary Outcome: Number of patients treated by Taxotere® with nail toxicity >= 2 (CTC-AE version 3.0) [ Time Frame: 4 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Number of day between inclusion and apparition of nail toxicity [ Time Frame: 4 months ]
- Necessity of local care, existence of pains [ Time Frame: 4 months ]
- Tolerance and compliance for the frozen glove [ Time Frame: 4 months ]
Original Secondary Outcome:
- Number of day between inclusion and apparition of nail toxicity [ Time Frame: 4 months ]
- Necessity of local care, existence of pains. [ Time Frame: 4 months ]
- Tolerance and compliance for the frozen glove. [ Time Frame: 4 months ]
Information By: Institut Paoli-Calmettes
Dates:
Date Received: June 19, 2009
Date Started: September 2006
Date Completion:
Last Updated: September 13, 2011
Last Verified: September 2011
