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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.


Phase 3
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms, Prostate Cancer, Nail Diseases

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Number of patients treated by Taxotere® with nail toxicity >= 2 (CTC-AE version 3.0)

Outcome Time Frame:

4 months

Safety Issue:

No

Principal Investigator

Carole TARPIN, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Paoli-Calmettes

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

CRYO 1/IPC 2005-007

NCT ID:

NCT00925418

Start Date:

September 2006

Completion Date:

July 2011

Related Keywords:

  • Breast Neoplasms
  • Prostate Cancer
  • Nail Diseases
  • Neoplasm
  • breast Neoplasm
  • docetaxel
  • Glove
  • Breast Neoplasms
  • Neoplasms
  • Nail Diseases
  • Prostatic Neoplasms

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