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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Institut Paoli-Calmettes

ClinicalTrials.gov Identifier:

NCT00925418

First received: June 19, 2009

Last updated: September 13, 2011

Last verified: September 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

June 19, 2009

Last Updated Date

September 13, 2011

Start Date ^ICMJE

September 2006

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00925418 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Breast Neoplasms
Prostate Cancer
Nail Diseases

Intervention ^ICMJE

Procedure: Frozen Glove

Using frozen glove during chemotherapy with Taxotere®

Study Arm (s)

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®

Intervention: Procedure: Frozen Glove

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

168

Completion Date

July 2011

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00925418

Other Study ID Numbers ^ICMJE

CRYO 1/IPC 2005-007

Has Data Monitoring Committee

Responsible Party

Institut Paoli-Calmettes

Study Sponsor ^ICMJE

Institut Paoli-Calmettes

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Carole TARPIN, MD

Institut Paoli-Calmettes

Information Provided By

Institut Paoli-Calmettes

Verification Date

September 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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