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

Prostate Cancer Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00925418
• Other study ID #: CRYO 1/IPC 2005-007
• Status: Completed
• Phase: Phase 3
• First received: June 19, 2009
• Last updated: September 13, 2011
• Start date: September 2006
• Est. completion date: July 2011

Study information

• Verified date: September 2011
• Source: Institut Paoli-Calmettes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: July 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Nail Diseases
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Frozen Glove
Using frozen glove during chemotherapy with Taxotere®

Locations

Country	Name	City	State
France	Institut PAOLI-CALMETTES	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients treated by Taxotere® with nail toxicity >= 2 (CTC-AE version 3.0)		4 months	No
Secondary	Number of day between inclusion and apparition of nail toxicity		4 months	No
Secondary	Necessity of local care, existence of pains		4 months	No
Secondary	Tolerance and compliance for the frozen glove		4 months	No

External Links

•   Official web site of the sponsor