Status:
COMPLETED
Evaluation of the Cryotherapy in the Prevention of Nails Toxicity Induced by Taxotere® in Breast or Prostate Cancer
Lead Sponsor:
Institut Paoli-Calmettes
Conditions:
Breast Neoplasms
Prostate Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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 pha...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2011
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT00925418
Start Date
September 1 2006
End Date
July 1 2011
Last Update
September 14 2011
Active Locations (1)
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1
Institut PAOLI-CALMETTES
Marseille, France