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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants not previously treated with anthracyclines | Other | No anthracycline treatment in the 6 months prior to inclusion. |
|
| Participants previously treated with anthracyclines | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dosage of B-type natriuretic peptide (NT-proBNP) | Other | NT-proBNP concentration assessed at the following time points :
|
| Measure | Description | Time Frame |
|---|---|---|
| Pre-operative Concentration of NT-proBNP | Mean concentration of NT-proBNP measured before surgery. | Before breast surgery |
| Concentration of NT-proBNP at the End of Intervention | Mean concentration of NT-proBNP measured at the end of intervention | At the end of breast surgery |
| Post-operative Concentration of NT-proBNP | Mean concentration of NT-proBNP measured 24 hours after breast surgery | 24 hours after breast surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GEKIERE Jean Pierre, MD | Institut Bergonié | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonié | Bordeaux | Aquitaine | 33000 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 :
|
| FG001 | Participants Previously Treated With Anthracyclines | Dosage of B-type natriuretic peptide (NT-proBNP): NT-proBNP concentration assessed at the following time points :
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 :
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pre-operative Concentration of NT-proBNP | Mean concentration of NT-proBNP measured before surgery. | Posted | Mean | Standard Deviation | pg/ml | Before breast surgery |
|
24 hours after surgery
Only mortality and serious adverse events were collected. These were collected in all included participants (29 +25 = 54 were included), and not only for those who completed the study (23 +20 = 43 completed the study) Non-serious adverse events were not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 :
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Simone Mathoulin-Pélissier, Director of Clinical Trials Unit | Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR | +33 5 56 33 33 33 | s.mathoulin@bordeaux.unicancer.fr |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C109794 | pro-brain natriuretic peptide (1-76) |
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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.
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|
| BG001 | Participants Previously Treated With Anthracyclines | Dosage of B-type natriuretic peptide (NT-proBNP): NT-proBNP concentration assessed at the following time points :
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Dosage of B-type natriuretic peptide (NT-proBNP): NT-proBNP concentration assessed at the following time points :
|
|
|
|
| Primary | Concentration of NT-proBNP at the End of Intervention | Mean concentration of NT-proBNP measured at the end of intervention | Participants with dosage available | Posted | Mean | Standard Error | pg/ml | At the end of breast surgery |
|
|
|
|
| Primary | Post-operative Concentration of NT-proBNP | Mean concentration of NT-proBNP measured 24 hours after breast surgery | Participants with NT-proBNP dosage available | Posted | Mean | Standard Deviation | pg/ml | 24 hours after breast surgery |
|
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 0 |
| EG001 | Participants Previously Treated With Anthracyclines | Dosage of B-type natriuretic peptide (NT-proBNP): NT-proBNP concentration assessed at the following time points :
| 0 | 25 | 0 | 25 | 0 | 0 |
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| D017437 |
| Skin and Connective Tissue Diseases |