COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00925418
Recruitment Status : Completed
First Posted : June 22, 2009
Last Update Posted : September 14, 2011
Information provided by (Responsible Party):
Institut Paoli-Calmettes

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 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 or disease Intervention/treatment Phase
Breast Neoplasms Prostate Cancer Nail Diseases Procedure: Frozen Glove Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : September 2006
Actual Primary Completion Date : September 2010
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Docetaxel

Arm Intervention/treatment
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®

Primary Outcome Measures :
  1. Number of patients treated by Taxotere® with nail toxicity >= 2 (CTC-AE version 3.0) [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Number of day between inclusion and apparition of nail toxicity [ Time Frame: 4 months ]
  2. Necessity of local care, existence of pains [ Time Frame: 4 months ]
  3. Tolerance and compliance for the frozen glove [ Time Frame: 4 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00925418

Layout table for location information
Marseille, France
Sponsors and Collaborators
Institut Paoli-Calmettes
Layout table for investigator information
Principal Investigator: Carole TARPIN, MD Institut Paoli-Calmettes
Additional Information:
Layout table for additonal information
Responsible Party: Institut Paoli-Calmettes Identifier: NCT00925418    
Other Study ID Numbers: CRYO 1/IPC 2005-007
First Posted: June 22, 2009    Key Record Dates
Last Update Posted: September 14, 2011
Last Verified: September 2011
Keywords provided by Institut Paoli-Calmettes:
breast Neoplasm
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Breast Neoplasms
Nail Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Breast Diseases
Skin Diseases