NCT02283983

Evaluation of Cryoprotection Induced Nail Toxicity Docetaxel Low Cumulative Dose

Evaluation of Cryoprotection of Nail Toxicity Induced by Docetaxel Low Cumulative Dose. Controlled, Randomized, Open, Multicentre Prospective.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 319 (actual)
• Sponsor: Centre Hospitalier Departemental Vendee · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

For the specific patient population studied receiving 5-Fluorouracil, epirubicin and cyclophosphamide - Docetaxel sequence (cumulative dose \<300 mg / m2), using a cryoprotection has never been assessed. The effectiveness of cryoprotection of onycholysis secondary to Docetaxel is not well established in this population (breast cancer in the adjuvant setting) and is based solely on a publication (Scotté) that does not contain the same therapeutic modalities (dose significantly higher). The few studies available have heterogeneous populations, nonrandomized, retrospective or with a small sample. By extension to what has been observed with higher cumulative doses of docetaxel, some teams offer mittens and booties chilled to their patients, a practice that is not the subject of a national consensus. The investigators wish to accurately assess the effectiveness of mittens and slippers chilled, their tolerance and their observance because of weak data on this specific population in the literature.

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
OTHER	mittens and booties
OTHER	cooling helmet

Timeline

• Start date: 2014-12-01
• Primary completion: 2019-09-01
• Completion: 2020-06-25
• First posted: 2014-11-05
• Last updated: 2024-10-09
• Results posted: 2024-10-09

Locations

10 sites across 1 country: France