Evaluation of the Cryotherapy in the Prevention of Nails Toxicity Induced by Taxotere® in Breast or Prostate Cancer (CRYO1)
Primary Purpose
Breast Neoplasms, Prostate Cancer, Nail Diseases
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Frozen Glove
Sponsored by
About this trial
This is an interventional prevention trial for Breast Neoplasms focused on measuring Neoplasm, breast Neoplasm, docetaxel, Glove
Eligibility 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
Sites / Locations
- Institut PAOLI-CALMETTES
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Without Glove
With Glove
Arm Description
Patients do not use frozen glove during chemotherapy with Taxotere®
Patients use frozen glove during chemotherapy with Taxotere®
Outcomes
Primary Outcome Measures
Number of patients treated by Taxotere® with nail toxicity >= 2 (CTC-AE version 3.0)
Secondary Outcome Measures
Number of day between inclusion and apparition of nail toxicity
Necessity of local care, existence of pains
Tolerance and compliance for the frozen glove
Full Information
NCT ID
NCT00925418
First Posted
June 19, 2009
Last Updated
September 13, 2011
Sponsor
Institut Paoli-Calmettes
1. Study Identification
Unique Protocol Identification Number
NCT00925418
Brief Title
Evaluation of the Cryotherapy in the Prevention of Nails Toxicity Induced by Taxotere® in Breast or Prostate Cancer
Acronym
CRYO1
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 Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Prostate Cancer, Nail Diseases
Keywords
Neoplasm, breast Neoplasm, docetaxel, Glove
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
168 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Without Glove
Arm Type
No Intervention
Arm Description
Patients do not use frozen glove during chemotherapy with Taxotere®
Arm Title
With Glove
Arm Type
Experimental
Arm Description
Patients use frozen glove during chemotherapy with Taxotere®
Intervention Type
Procedure
Intervention Name(s)
Frozen Glove
Intervention Description
Using frozen glove during chemotherapy with Taxotere®
Primary Outcome Measure Information:
Title
Number of patients treated by Taxotere® with nail toxicity >= 2 (CTC-AE version 3.0)
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Number of day between inclusion and apparition of nail toxicity
Time Frame
4 months
Title
Necessity of local care, existence of pains
Time Frame
4 months
Title
Tolerance and compliance for the frozen glove
Time Frame
4 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carole TARPIN, MD
Organizational Affiliation
Institut Paoli-Calmettes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut PAOLI-CALMETTES
City
Marseille
Country
France
12. IPD Sharing Statement
Links:
URL
http://www.institutpaolicalmettes.fr
Description
Official web site of the sponsor
Learn more about this trial
Evaluation of the Cryotherapy in the Prevention of Nails Toxicity Induced by Taxotere® in Breast or Prostate Cancer
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