Evaluation of the Cryotherapy in the Prevention of Nails... | NCT00925418

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

NCT00925418

Sponsor

Institut Paoli-Calmettes

Status

Completed

Last Update Posted

Sep 14, 2011Estimated

Enrollment

168Estimated

Phase

Phase 3

Conditions

Breast Neoplasms
Prostate Cancer
Nail Diseases

Interventions

Frozen Glove

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Sep 2010Actual

Completion Date

Jul 2011Actual

First Submitted Date

Jun 19, 2009

First Submission Date that Met QC Criteria

Jun 19, 2009

First Posted Date

Jun 22, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2011

Last Update Posted Date

Sep 14, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

168Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Without Glove	No Intervention	Patients do not use frozen glove during chemotherapy with Taxotere®
With Glove	Experimental	Patients use frozen glove during chemotherapy with Taxotere®	Procedure: Frozen Glove

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Frozen Glove	Procedure	Using frozen glove during chemotherapy with Taxotere®	With Glove

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients treated by Taxotere® with nail toxicity >= 2 (CTC-AE version 3.0)		4 months

Secondary Outcomes

Measure	Description	Time Frame
Number of day between inclusion and apparition of nail toxicity		4 months
Necessity of local care, existence of pains		4 months
Tolerance and compliance for the frozen glove

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carole TARPIN, MD	Institut Paoli-Calmettes	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut PAOLI-CALMETTES		Marseille			France

Label	URL
Official web site of the sponsor	View source

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D011471	Prostatic Neoplasms
D009260	Nail Diseases
D009369	Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided