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Evaluation of the Cryotherapy in the Prevention of Nails Toxicity Induced by Taxotere® in Breast or Prostate Cancer (CRYO1)

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ClinicalTrials.gov Identifier: NCT00925418
Recruitment Status : Completed
First Posted : June 22, 2009
Last Update Posted : September 14, 2011
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes

Tracking Information
First Submitted Date  ICMJE June 19, 2009
First Posted Date  ICMJE June 22, 2009
Last Update Posted Date September 14, 2011
Study Start Date  ICMJE September 2006
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2009)
Number of patients treated by Taxotere® with nail toxicity >= 2 (CTC-AE version 3.0) [ Time Frame: 4 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00925418 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2009)
  • 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 Measures  ICMJE
 (submitted: June 19, 2009)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Cryotherapy in the Prevention of Nails Toxicity Induced by Taxotere® in Breast or Prostate Cancer
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Breast Neoplasms
  • Prostate Cancer
  • Nail Diseases
Intervention  ICMJE Procedure: Frozen Glove
Using frozen glove during chemotherapy with Taxotere®
Study Arms  ICMJE
  • No Intervention: Without Glove
    Patients do not use frozen glove during chemotherapy with Taxotere®
  • Experimental: With Glove
    Patients use frozen glove during chemotherapy with Taxotere®
    Intervention: Procedure: Frozen Glove
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 19, 2009)
168
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with hormono-resistant breast cancer or metastatic prostate cancer treated by chemotherapy with Taxotere®.
  • Patients aged 18 and older
  • Nail toxicity < grade 2 (CTC-AE version 3.0)
  • Informed patients with signed consent

Exclusion Criteria:

  • History of treatment with taxane
  • Raynaud syndrome
  • Distal metastasis in superior extremity
  • Nail diseases
  • Distal arteriopathy
  • Cold intolerance
  • Peripheral neuropathy>=2
  • Pregnancy, breast feeding
  • Unable to give informed consent
  • Unable to have a medical follow-up for social, geographical, family or psychological reasons
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00925418
Other Study ID Numbers  ICMJE CRYO 1/IPC 2005-007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut Paoli-Calmettes
Study Sponsor  ICMJE Institut Paoli-Calmettes
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carole TARPIN, MD Institut Paoli-Calmettes
PRS Account Institut Paoli-Calmettes
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP