Evaluation of the Cryotherapy in the Prevention of Nails Toxicity Induced by Taxotere® in Breast or Prostate Cancer (CRYO1)

This study has been completed.
Information provided by (Responsible Party):
Institut Paoli-Calmettes
ClinicalTrials.gov Identifier:
First received: June 19, 2009
Last updated: September 13, 2011
Last verified: September 2011

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 Intervention Phase
Breast Neoplasms
Prostate Cancer
Nail Diseases
Procedure: Frozen Glove
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

Further study details as provided by Institut Paoli-Calmettes:

Primary Outcome Measures:
  • Number of patients treated by Taxotere® with nail toxicity >= 2 (CTC-AE version 3.0) [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of day between inclusion and apparition of nail toxicity [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Necessity of local care, existence of pains [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Tolerance and compliance for the frozen glove [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 168
Study Start Date: September 2006
Study Completion Date: July 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00925418

Marseille, France
Sponsors and Collaborators
Institut Paoli-Calmettes
Principal Investigator: Carole TARPIN, MD Institut Paoli-Calmettes
  More Information

Additional Information:
Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT00925418     History of Changes
Other Study ID Numbers: CRYO 1/IPC 2005-007 
Study First Received: June 19, 2009
Last Updated: September 13, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Paoli-Calmettes:
breast Neoplasm

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

ClinicalTrials.gov processed this record on May 25, 2016