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

Primary Purpose

Breast Neoplasms

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
mittens and booties
cooling helmet
Sponsored by
Centre Hospitalier Departemental Vendee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Institut de cancérologie de l'Ouest - Angers
  • Centre Hospitalier de Cholet
  • CHD Vendee
  • CH du Mans
  • Centre hospitalier Bretagne Sud
  • Centre Catherine de Sienne
  • Institut de cancérologie de l'Ouest - Nantes
  • Clinique Mutualiste de l'Estuaire
  • Centre d'Oncologie Saint-Yves
  • CHBA Vannes

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard cryoprotection

Cryoprotection with mittens and booties

Arm Description

Proposal helmet without mittens and booties

Standard cryoprotection with mittens and booties

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 3, 2014
Last Updated
August 27, 2020
Sponsor
Centre Hospitalier Departemental Vendee
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1. Study Identification

Unique Protocol Identification Number
NCT02283983
Brief Title
Evaluation of Cryoprotection Induced Nail Toxicity Docetaxel Low Cumulative Dose
Acronym
BANQUISE
Official Title
Evaluation of Cryoprotection of Nail Toxicity Induced by Docetaxel Low Cumulative Dose. Controlled, Randomized, Open, Multicentre Prospective.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
June 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Departemental Vendee

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard cryoprotection
Arm Type
Active Comparator
Arm Description
Proposal helmet without mittens and booties
Arm Title
Cryoprotection with mittens and booties
Arm Type
Experimental
Arm Description
Standard cryoprotection with mittens and booties
Intervention Type
Other
Intervention Name(s)
mittens and booties
Intervention Type
Other
Intervention Name(s)
cooling helmet
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank PRIOU, PH
Organizational Affiliation
CHD Vendee La Roche sur Yon
Official's Role
Study Director
Facility Information:
Facility Name
Institut de cancérologie de l'Ouest - Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Centre Hospitalier de Cholet
City
Cholet
ZIP/Postal Code
49300
Country
France
Facility Name
CHD Vendee
City
La Roche sur Yon
ZIP/Postal Code
85925
Country
France
Facility Name
CH du Mans
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Centre hospitalier Bretagne Sud
City
Lorient
ZIP/Postal Code
56100
Country
France
Facility Name
Centre Catherine de Sienne
City
Nantes
ZIP/Postal Code
44202
Country
France
Facility Name
Institut de cancérologie de l'Ouest - Nantes
City
Saint-Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Clinique Mutualiste de l'Estuaire
City
Saint-Nazaire
ZIP/Postal Code
44606
Country
France
Facility Name
Centre d'Oncologie Saint-Yves
City
Vannes
ZIP/Postal Code
56000
Country
France
Facility Name
CHBA Vannes
City
Vannes
ZIP/Postal Code
56000
Country
France

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Cryoprotection Induced Nail Toxicity Docetaxel Low Cumulative Dose

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