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

Study Overview
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Brief Summary
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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

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

Conditions
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Breast Neoplasms, Prostate Cancer, Nail Diseases

Intervention / Treatment
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* Procedure: Frozen Glove


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Without Glove<br>Patients do not use frozen glove during chemotherapy with Taxotere® | |
| Experimental: With Glove<br>Patients use frozen glove during chemotherapy with Taxotere® | Procedure: Frozen Glove<br>* Using frozen glove during chemotherapy with Taxotere®<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients treated by Taxotere® with nail toxicity >= 2 (CTC-AE version 3.0) |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of day between inclusion and apparition of nail toxicity |  | 4 months | 
| Necessity of local care, existence of pains |  | 4 months | 
| Tolerance and compliance for the frozen glove |  | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neoplasm, breast Neoplasm, docetaxel, Glove