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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00925418

Acronym

CRYO1

Enrollment

168

Registered

2009-06-22

Start date

2006-09-30

Completion date

2011-07-31

Last updated

2011-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms, Nail Diseases, Prostate Cancer

Keywords

Neoplasm, breast Neoplasm, docetaxel, Glove

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

Interventions

PROCEDUREFrozen Glove

Using frozen glove during chemotherapy with Taxotere®

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026