Evaluation of the Cryotherapy in the Prevention of Nails Toxicity Induced by Taxotere® in Breast or Prostate Cancer
NCT ID: NCT00925418
Last Updated: 2011-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
168 participants
INTERVENTIONAL
2006-09-30
2011-07-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Without Glove
Patients do not use frozen glove during chemotherapy with Taxotere®
No interventions assigned to this group
With Glove
Patients use frozen glove during chemotherapy with Taxotere®
Frozen Glove
Using frozen glove during chemotherapy with Taxotere®
Interventions
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Frozen Glove
Using frozen glove during chemotherapy with Taxotere®
Eligibility Criteria
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Inclusion Criteria
* Patients aged 18 and older
* Nail toxicity \< grade 2 (CTC-AE version 3.0)
* Informed patients with signed consent
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Institut Paoli-Calmettes
OTHER
Responsible Party
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Principal Investigators
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Carole TARPIN, MD
Role: PRINCIPAL_INVESTIGATOR
Institut Paoli-Calmettes
Locations
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Institut PAOLI-CALMETTES
Marseille, , France
Countries
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Related Links
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Official web site of the sponsor
Other Identifiers
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CRYO 1/IPC 2005-007
Identifier Type: -
Identifier Source: org_study_id
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