Evaluation of Cryoprotection Induced Nail Toxicity Docetaxel Low Cumulative Dose (BANQUISE)

August 27, 2020 updated by: Centre Hospitalier Departemental Vendee

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • Institut de Cancérologie de l'Ouest - Angers
      • Cholet, France, 49300
        • Centre Hospitalier de Cholet
      • La Roche sur Yon, France, 85925
        • CHD Vendee
      • Le Mans, France, 72000
        • CH du Mans
      • Lorient, France, 56100
        • Centre Hospitalier Bretagne Sud
      • Nantes, France, 44202
        • Centre Catherine de Sienne
      • Saint-Herblain, France, 44805
        • Institut de Cancérologie de l'Ouest - Nantes
      • Saint-Nazaire, France, 44606
        • Clinique Mutualiste de l'Estuaire
      • Vannes, France, 56000
        • CHBA Vannes
      • Vannes, France, 56000
        • Centre d'Oncologie Saint-Yves

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • upper age to 18 years
  • mammary adenocarcinoma nonmetastatic and histologically proven
  • wait under an adjuvant or neoadjuvant chemotherapy according to the following conventional scheme: 3 cycles of F5-Fluorouracil, epirubicin and cyclophosphamide 100 (500 or 5-Fluorouracil 600 mg / m² J1, Epirubicin 100 mg / m² J1, Cyclophosphamide 500 or 600 mg / m² J1 or 3 cycles of Epiribucin and Cyclophosphamide 100) followed by 3 cycles of docetaxel, 100 mg / m², +/- trastuzumab if Her2+++
  • Patient with the capacity/faculties to understand a newsletter and sign an informed consent
  • Patient receiving social coverage
  • Patient who can be treated and followed in the center for a period of at least one year
  • WHO scale 0 or 1

Exclusion Criteria:

  • Age below 18 years
  • Diseases of the scalp or whatever hair-showing against helmet or alopecia
  • Using pre nail resin before and per chemotherapy
  • mammary adenocarcinoma stage IV
  • Indication of docetaxel for cancer of another organ than breast
  • Treatment processing or programmed during chemotherapy with an innovative molecule being evaluated
  • Raynaud's syndrome, cold agglutinin disease, cryoglobulinemia and cryofibrinogenemia.
  • Uncontrolled severe arterial disease.
  • Presence of a device> grade 1 neuropathy before the start of chemotherapy
  • Patient unable to submit the protocol followed for psychological, social, family or geographical
  • Patient with an incompatible underlying disease or concomitant with the inclusion in the trial, whether psychiatric or somatic
  • Patient trust, guardianship, under legal protection measure, deprived of freedom
  • Male

  • Criteria for non randomization (before the first course of docetaxel) :

    • Presence of peripheral neuropathy> grade 1 after the first 3 cycles of 5-Fluorouracil, epirubicin and cyclophosphamide 100.
    • Presence of a nail or skin toxicity> grade 1 after 3 cycles of 5-Fluorouracil, epirubicin and cyclophosphamide 100.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard cryoprotection
Proposal helmet without mittens and booties
Other: cooling helmet
Experimental: Cryoprotection with mittens and booties
Standard cryoprotection with mittens and booties
Other: cooling helmet
Other: mittens and booties

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of the occurrence of nail toxicity of grade 2 of Common Toxicity Criteria for Adverse Effects V4.0 evaluated at 8 weeks post infusion of docetaxel.
Time Frame: 8 weeks post infusion of docetaxel
8 weeks post infusion of docetaxel

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Departemental Vendee

Investigators

  • Study Director: Frank PRIOU, PH, Chd Vendee La Roche Sur Yon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2014

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

June 25, 2020

Study Registration Dates

First Submitted

November 3, 2014

First Submitted That Met QC Criteria

November 4, 2014

First Posted (Estimate)

November 5, 2014

Study Record Updates

Last Update Posted (Actual)

August 28, 2020

Last Update Submitted That Met QC Criteria

August 27, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHD 097-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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