MedTrace Logo

Evaluation of Cryoprotection Induced Nail Toxicity Docetaxel Low Cumulative Dose

NCT02283983 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 319

Last updated 2024-10-09

Study results available
· View outcomes & findings →

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

OTHER

mittens and booties

OTHER

cooling helmet

Sponsors & Collaborators

  • Centre Hospitalier Departemental Vendee

    lead OTHER

Principal Investigators

  • Frank PRIOU, PH · CHD Vendee La Roche sur Yon

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2019-09-30
Completion
2020-06-25

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02283983 on ClinicalTrials.gov