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

Sponsor:	Institut Paoli-Calmettes
Information provided by (Responsible Party):	Institut Paoli-Calmettes
ClinicalTrials.gov Identifier:	NCT00925418

Purpose

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 III

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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Nail Diseases Prostate Cancer

Drug Information available for: Docetaxel

U.S. FDA Resources

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®

Eligibility

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

Criteria

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

Contacts and Locations

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

Locations

France
Institut PAOLI-CALMETTES
Marseille, France

Sponsors and Collaborators

Institut Paoli-Calmettes

Investigators

Principal Investigator:

Carole TARPIN, MD

Institut Paoli-Calmettes

More Information

Additional Information:

Official web site of the sponsor This link exits the ClinicalTrials.gov site

No publications provided

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 - French Health Products Safety Agency

Keywords provided by Institut Paoli-Calmettes:

Neoplasm
breast Neoplasm
docetaxel
Glove

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms
Nail Diseases
Prostatic Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012