Clinical trial NCT02283983: Evaluation of Cryoprotection Induced Nail Toxicity Docetaxel Low Cumulative Dose
Official title: Evaluation of Cryoprotection of Nail Toxicity Induced by Docetaxel Low Cumulative Dose. Controlled, Randomized, Open, Multicentre Prospective.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2014-11-05
Enrollment: 319
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: 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.
timeFrame: 8 weeks post infusion of docetaxel
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Institut de cancérologie de l'Ouest - Angers
city: Cholet
country: France
facility: Centre Hospitalier de Cholet
city: La Roche sur Yon
country: France
facility: CHD Vendee
city: Le Mans
country: France
facility: CH du Mans
city: Lorient
country: France
facility: Centre hospitalier Bretagne Sud
city: Nantes
country: France
facility: Centre Catherine de Sienne
city: Saint-Herblain
country: France
facility: Institut de cancérologie de l'Ouest - Nantes
city: Saint-Nazaire
country: France
facility: Clinique Mutualiste de l'Estuaire
city: Vannes
country: France
facility: Centre d'Oncologie Saint-Yves
city: Vannes
country: France
facility: CHBA Vannes
Study officials:
affiliation: CHD Vendee La Roche sur Yon
name: Frank PRIOU, PH
role: STUDY_DIRECTOR
References: