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

Institut Paoli-Calmettes

Status and phase: Completed; Phase 3

Conditions: Nail Diseases; Breast Neoplasms; Prostate Cancer

Treatments: Procedure: Frozen Glove

Study type: Interventional

Funder types: Other

Identifiers

NCT00925418

CRYO 1/IPC 2005-007

Details and patient eligibility

About

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

Enrollment: 168 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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168 participants in 2 patient groups

Without Glove

No Intervention group

Description:

Patients do not use frozen glove during chemotherapy with Taxotere®

With Glove

Experimental group

Description:

Patients use frozen glove during chemotherapy with Taxotere®

Treatment:

Procedure: Frozen Glove