Breast Cancer
Conditions
Keywords
Anesthesia
Brief summary
The cardiotoxicity of anthracyclines chemotherapy remains a major problem, despite clinical and echocardiographic monitoring. In the case of treatment for breast cancer, surgery requiring general anesthesia may follow chemotherapy. Although a possible interaction between general anesthetics and anthracyclines on systolic function is only rarely mentioned, some cases of heart failure and / or conduction disturbances peranesthésique were observed in patients treated or previously treated with anthracyclines. The determination of concentration of BNP is a diagnostic tool used in the detection of heart failure and acute coronary syndromes. The question of a possible synergism between cardiotoxic anthracyclines and anesthetic agents arises. Given its minimally invasive nature and its diagnostic value, the BNP assay might thus allow to highlight a possible subclinical deficiency. To our knowledge, there is very little data regarding a possible synergism between cardiotoxic anthracyclines and anesthetic agents.
Detailed description
The cardiotoxicity of anthracyclines chemotherapy remains a major problem, despite clinical and echocardiographic monitoring. In the case of treatment for breast cancer, surgery requiring general anesthesia may follow chemotherapy. Although a possible interaction between general anesthetics and anthracyclines on systolic function is only rarely mentioned, some cases of heart failure and / or conduction disturbances peranesthésique were observed in patients treated or previously treated with anthracyclines. The determination of concentration of BNP is a diagnostic tool used in the detection of heart failure and acute coronary syndromes. In fact, it is one of the most sensitive markers of impaired myocardial function, and an increase in interest rates may precede any other biological changes. In a patient who received anthracycline, although it remains asymptomatic elevation of NT-proBNP concentration may persist for some months after exposure, and that, whatever the doses received. The question of a possible synergism between cardiotoxic anthracyclines and anesthetic agents arises. Given its minimally invasive nature and its diagnostic value, the BNP assay might thus allow to highlight a possible subclinical deficiency. To our knowledge, there is very little data regarding a possible synergism between cardiotoxic anthracyclines and anesthetic agents.
Interventions
OTHERDosage of B-type natriuretic peptide (NT-proBNP)
NT-proBNP concentration assessed at the following time points : * T0: before induction of general anesthesia, NT-proBNP measurement * T1: 30 minutes after induction of general anesthesia * T2: at the end of the procedure * T3: in the postoperative period, 6 hours after the end of the procedure * T4: in the postoperative period, 24 hours after the end of the procedure
Sponsors
Institut Bergonié
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
This feasibility study will describe the evolution of NT-ProBNP during general anesthesia in patients undergoing surgery for breast cancer, depending on whether or not they have previously been treated with anthracyclines. The data collected in this study will be used later in a clinical trial comparing the occurrence of subclinical heart failure during breast cancer surgery under general anesthesia, depending on whether patients have been sensitized to anthracyclines.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women over 18 years with effective contraceptive method (if applicable) * NT-proBNP \<125 pg / ml * ASA 1 or 2, * Breast cancer histologically proven * Mastectomy or lumpectomy * Neoadjuvant chemotherapy with anthracyclines in 6 months or received no chemotherapy with anthracyclines, * Patients who received the briefing and signed the informed consent * Patients affiliated to a social security system.
Exclusion criteria
* Patients for whom the maintenance of general anesthesia does not use halogenated. * Renal impairment: Creatinine clearance \<60 ml / min, * Patients who for reasons psychological, social, family or geographical could not be treated or monitored regularly according to the criteria of the study, patients deprived of liberty or under guardianship. * Presence of a cardiopathy * Pregnant Women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pre-operative Concentration of NT-proBNP | Before breast surgery | Mean concentration of NT-proBNP measured before surgery. |
| Concentration of NT-proBNP at the End of Intervention | At the end of breast surgery | Mean concentration of NT-proBNP measured at the end of intervention |
| Post-operative Concentration of NT-proBNP | 24 hours after breast surgery | Mean concentration of NT-proBNP measured 24 hours after breast surgery |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Participants Not Previously Treated With Anthracyclines No anthracycline treatment in the 6 months prior to inclusion.
Dosage of B-type natriuretic peptide (NT-proBNP): NT-proBNP concentration assessed at the following time points :
* T0: before induction of general anesthesia, NT-proBNP measurement
* T1: 30 minutes after induction of general anesthesia
* T2: at the end of the procedure
* T3: in the postoperative period, 6 hours after the end of the procedure
* T4: in the postoperative period, 24 hours after the end of the procedure | 23 |
| Participants Previously Treated With Anthracyclines Dosage of B-type natriuretic peptide (NT-proBNP): NT-proBNP concentration assessed at the following time points :
* T0: before induction of general anesthesia, NT-proBNP measurement
* T1: 30 minutes after induction of general anesthesia
* T2: at the end of the procedure
* T3: in the postoperative period, 6 hours after the end of the procedure
* T4: in the postoperative period, 24 hours after the end of the procedure | 20 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Dosage of NT-proBNP not performed | 6 | 5 |
Baseline characteristics
| Characteristic | Participants Previously Treated With Anthracyclines | Total | Participants Not Previously Treated With Anthracyclines |
|---|---|---|---|
| Age, Continuous | 49.3 years STANDARD_DEVIATION 8.5 | 52 years STANDARD_DEVIATION 8 | 56.8 years STANDARD_DEVIATION 8.4 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment France | 20 participants | 43 participants | 23 participants |
| Sex: Female, Male Female | 20 Participants | 43 Participants | 23 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 | 0 / 29 | 0 / 25 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 29 | 0 / 25 |
Outcome results
Primary
Concentration of NT-proBNP at the End of Intervention
Mean concentration of NT-proBNP measured at the end of intervention
Time frame: At the end of breast surgery
Population: Participants with dosage available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Not Previously Treated With Anthracyclines | Concentration of NT-proBNP at the End of Intervention | 42.2 pg/ml | Standard Error 28 |
| Participants Previously Treated With Anthracyclines | Concentration of NT-proBNP at the End of Intervention | 34.6 pg/ml | Standard Error 20 |
p-value: 0.492Wilcoxon (Mann-Whitney)
Primary
Post-operative Concentration of NT-proBNP
Mean concentration of NT-proBNP measured 24 hours after breast surgery
Time frame: 24 hours after breast surgery
Population: Participants with NT-proBNP dosage available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Not Previously Treated With Anthracyclines | Post-operative Concentration of NT-proBNP | 107.6 pg/ml | Standard Deviation 79.1 |
| Participants Previously Treated With Anthracyclines | Post-operative Concentration of NT-proBNP | 75.9 pg/ml | Standard Deviation 61.1 |
p-value: 0.183Wilcoxon (Mann-Whitney)
Primary
Pre-operative Concentration of NT-proBNP
Mean concentration of NT-proBNP measured before surgery.
Time frame: Before breast surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Not Previously Treated With Anthracyclines | Pre-operative Concentration of NT-proBNP | 38.9 pg/ml | Standard Deviation 27 |
| Participants Previously Treated With Anthracyclines | Pre-operative Concentration of NT-proBNP | 32.2 pg/ml | Standard Deviation 18.4 |
p-value: 0.714Wilcoxon (Mann-Whitney)