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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00925418
Other study ID # CRYO 1/IPC 2005-007
Secondary ID
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


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
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