Evaluation of Cryoprotection Induced Nail Toxicity Docetaxel Low Cumulative Dose
Breast Neoplasms
Conditions: official terms
Breast Neoplasms
Study Type
Study Phase
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Name: mittens and booties Type: Other
Name: cooling helmet Type: Other
Overall Status
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
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.
Institut de cancérologie de l'Ouest - Angers
Angers, France
Status: Recruiting
Centre Hospitalier de Cholet
Cholet, France
Status: Recruiting
CHD Vendee
La Roche sur Yon, France
Status: Recruiting
Centre hospitalier Bretagne Sud
Lorient, France
Status: Recruiting
Centre Catherine de Sienne
Nantes, France
Status: Recruiting
Institut de cancérologie de l'Ouest - Nantes
Saint-Herblain, France
Status: Recruiting
Clinique Mutualiste de l'Estuaire
Saint-Nazaire, France
Status: Recruiting
Centre d'Oncologie Saint-Yves
Vannes, France
Status: Recruiting
CHBA Vannes
Vannes, France
Status: Not yet recruiting
Start Date
December 2014
Completion Date
November 2017
Centre Hospitalier Departemental Vendee
Centre Hospitalier Departemental Vendee
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page