Status:
COMPLETED
Evaluation of Cryoprotection Induced Nail Toxicity Docetaxel Low Cumulative Dose
Lead Sponsor:
Centre Hospitalier Departemental Vendee
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
NA
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 assess...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2020
Estimated Enrollment :
319 Patients enrolled
Trial Details
Trial ID
NCT02283983
Start Date
December 1 2014
End Date
June 25 2020
Last Update
October 9 2024
Active Locations (10)
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1
Institut de cancérologie de l'Ouest - Angers
Angers, France, 49933
2
Centre Hospitalier de Cholet
Cholet, France, 49300
3
CHD Vendee
La Roche-sur-Yon, France, 85925
4
CH du Mans
Le Mans, France, 72000