Breast Neoplasms
Conditions
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.
Interventions
OTHERmittens and booties
OTHERcooling helmet
Sponsors
Centre Hospitalier Departemental Vendee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| 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. | 8 weeks post infusion of docetaxel |
Countries
France
Participant flow
Pre-assignment details
Of 319 enrolled participants, 280 met inclusion criteria and were randomized to treatment
Participants by arm
| Arm | Count |
|---|---|
| Cryoprotection With Mittens and Booties Standard cryoprotection with mittens and booties
mittens and booties
cooling helmet | 141 |
| Standard Cryoprotection Proposal helmet without mittens and booties
cooling helmet | 133 |
| Total | 274 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Inclusion criteria not met | 0 | 1 |
| Overall Study | Lost to Follow-up | 9 | 8 |
| Overall Study | Physician Decision | 2 | 4 |
| Overall Study | Protocol Violation | 0 | 4 |
| Overall Study | Relapse | 1 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 2 |
Baseline characteristics
| Characteristic | Cryoprotection With Mittens and Booties | Standard Cryoprotection | Total |
|---|---|---|---|
| Age, Continuous | 55 years STANDARD_DEVIATION 11 | 54 years STANDARD_DEVIATION 12 | 54 years STANDARD_DEVIATION 11 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 141 Participants | 133 Participants | 274 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 141 | 0 / 139 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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
Population: Intention-to-treat analysis. 6 patients removed from the analysis because no taxotere treatment was performed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cryoprotection With Mittens and Booties | 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. | 26 Participants |
| Standard Cryoprotection | 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. | 49 Participants |
p-value: <0.001Mixed Models Analysis