Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Nail Diseases | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Frozen Glove | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Without Glove
- description
- Patients do not use frozen glove during chemotherapy with Taxotere®
- type
- EXPERIMENTAL
- label
- With Glove
- description
- Patients use frozen glove during chemotherapy with Taxotere®
- interventionNames
- Procedure: Frozen Glove
Primary outcomes (1)
- measure
- Number of patients treated by Taxotere® with nail toxicity >= 2 (CTC-AE version 3.0)
- timeFrame
- 4 months
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available