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

Sponsor

Institut Paoli-Calmettes (Other)

Overall Status

Completed

CT.gov ID

NCT00925418

Collaborator

(none)

168

Enrollment

Location

Arms

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms Prostate Cancer Nail Diseases	Procedure: Frozen Glove	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

168 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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.

Study Start Date :

Sep 1, 2006

Actual Primary Completion Date :

Sep 1, 2010

Actual Study Completion Date :

Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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®

Arm

Intervention/Treatment

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®

Outcome Measures

Primary Outcome Measures

Number of patients treated by Taxotere® with nail toxicity >= 2 (CTC-AE version 3.0) [4 months]

Secondary Outcome Measures

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 [4 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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