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Completed

NCT Number: NCT00925418

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

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

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Key information

Conditions

Breast Neoplasms Breast Diseases Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Nail Diseases Neoplasms Neoplasms by Site Prostate Cancer Prostatic Diseases Prostatic Neoplasms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Institut PAOLI-CALMETTES

Marseille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Frozen Glove

Procedure

Using frozen glove during chemotherapy with Taxotere®

Primary outcomes

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

    Time frame: 4 months

Secondary outcomes

  1. Number of day between inclusion and apparition of nail toxicity

    Time frame: 4 months

  2. Necessity of local care, existence of pains

    Time frame: 4 months

  3. Tolerance and compliance for the frozen glove

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Official study title

Randomized Trial Evaluating the Cryotherapy in the Prevention of Nails Toxicity Induced by Taxotere® in Patient Treated for Breast or Prostate Cancer.

Acronym: CRYO1

Important dates

Study start
2006
Primary completion
2010
Study completion
2011
First posted
Jun 22, 2009
Registry last updated
Sep 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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