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

NCT00925418 | Completed Phase 3

• 1 other identifier: CRYO 1/IPC 2005-007
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Neoplasms; Prostate Cancer; Nail Diseases

Keywords

Neoplasm; breast Neoplasm; docetaxel; Glove

Outcome Measures

Primary Outcomes (1)

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

  4 months

Secondary Outcomes (3)

• 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

Study Arms (2)

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

Frozen Glove PROCEDURE

Using frozen glove during chemotherapy with Taxotere®

With Glove

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Sites (1)

Institut PAOLI-CALMETTES

Marseille, France

Location

Related Links

• Official web site of the sponsor

MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms; Nail Diseases; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Carole TARPIN, MD

  Institut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2009
• First Posted: June 22, 2009
• Study Start: September 1, 2006
• Primary Completion: September 1, 2010
• Study Completion: July 1, 2011
• Last Updated: September 14, 2011

Record last verified: 2011-09

Locations

FR (1)