Evolution Natriuretic Peptide Concentrations of B-type (BNP) During General Anesthesia Under Propofol and Sevoflurane Association in Patients Previously Sensitized to Anthracyclines

Breast Cancer Clinical Trial

— PEPNATB  

Official title:

Evolution Natriuretic Peptide Concentrations of B-type (BNP) During General Anesthesia Under Propofol and Sevoflurane Association in Patients Previously Sensitized to Anthracyclines. Pilot Study in Patients Operated on for Breast Cancer. Monocentric Study Feasibility.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01754597
• Other study ID #: IB2009-39
• Status: Completed
• Phase: N/A
• First received: November 6, 2012
• Last updated: November 25, 2015
• Start date: September 2009
• Est. completion date: December 2012

Study information

• Verified date: November 2015
• Source: Institut Bergonié
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: National Security Agency of Medicines and Health Products
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Peptide Natriurétique de type B
Peptide Natriurétique de type B

Locations

Country	Name	City	State
France	Institut Bergonié	Bordeaux	Aquitaine

Sponsors (1)

Lead Sponsor	Collaborator
Institut Bergonié

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Describe the evolution of the concentrations of NT-proBNP, through repeated dosing during general anesthesia in patients operated on for breast cancer and anthracycline-sensitized or not	Describe the evolution of the concentrations of NT-proBNP, through repeated dosing during general anesthesia in patients operated on for breast cancer and anthracycline-sensitized or not	3 years	No
Secondary	Depending on the sensitivity to anthracyclines, study the proportion of patients with subclinical heart failure in the general anesthesia during surgery for breast cancer	Depending on the sensitivity to anthracyclines, study the proportion of patients with subclinical heart failure in the general anesthesia during surgery for breast cancer; In patients treated with anthracyclines, highlight the factors associated (cumulative dose of anthracycline front, left breast radiotherapy) to subclinical heart failure; In patients treated with anthracyclines, assess describe the relationship between the dose of anthracycline received preoperative and percentage of maximum variation of the concentration of NT-proBNP in the first 24 hours after surgery	3 years	No

External Links

•   Registre des essais cliniques de l'INCa
•   Site internet du promoteur, l'Institut Bergonié