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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

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


Condition or disease Intervention/treatment Phase
Breast Neoplasms Prostate Cancer Nail Diseases Procedure: Frozen Glove Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Trial Evaluating the Cryotherapy in the Prevention of Nails Toxicity Induced by Taxotere® in Patient Treated for Breast or Prostate Cancer.
Study Start Date : September 2006
Actual Primary Completion Date : September 2010
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Docetaxel
U.S. FDA Resources

Arm Intervention/treatment
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®
Procedure: Frozen Glove
Using frozen glove during chemotherapy with Taxotere®



Primary Outcome Measures :
  1. Number of patients treated by Taxotere® with nail toxicity >= 2 (CTC-AE version 3.0) [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Number of day between inclusion and apparition of nail toxicity [ Time Frame: 4 months ]
  2. Necessity of local care, existence of pains [ Time Frame: 4 months ]
  3. Tolerance and compliance for the frozen glove [ Time Frame: 4 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00925418


Locations
France
Institut PAOLI-CALMETTES
Marseille, France
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
Principal Investigator: Carole TARPIN, MD Institut Paoli-Calmettes

Additional Information:
Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT00925418     History of Changes
Other Study ID Numbers: CRYO 1/IPC 2005-007
First Posted: June 22, 2009    Key Record Dates
Last Update Posted: September 14, 2011
Last Verified: September 2011

Keywords provided by Institut Paoli-Calmettes:
Neoplasm
breast Neoplasm
docetaxel
Glove

Additional relevant MeSH terms:
Prostatic Neoplasms
Neoplasms
Breast Neoplasms
Nail Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Breast Diseases
Skin Diseases
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action