breast neoplasms, anthracyclines, adjuvant chemotherapy.
Conditions
Interventions
Experimental group of 10 women with primary breast cancer, virgin chemotherapy with anthracyclines. Control group of 10 women with primary breast cancer, virgin chemotherapy with anthracyclines. The g
The cuff should be placed without an arm, or insufflate the cuff up to 200 mmHg to 250 mmHg, and hold it for 5 minutes, infused with 5 minutes of reperfusion (total deflation). This procedure is done
Device
E02.592.325
Sponsors
Faculdade de Medicina do ABC (FMABC)
Faculdade de Medicina do ABC (FMABC)
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Sign the informed consent form prior to any study procedure; histologically proven breast cancer for chemotherapy with anthracyclics for neoadjuvant or adjuvant treatment; women; older than 18 years; Estimated life expectancy over six months.
Exclusion criteria
Exclusion criteria: Uncontrolled active infection with significant clinical impairment of ventricular ejection fraction (LVEF assessed by echocardiogram should be above the lower limit of normal respective study center); severe cardiac valvulopathy; myocardial infarction; unstable angina pectoris; uncontrolled hypertension or uncontrolled arrhythmias up to six months prior to admission to the study; anterior or concomitant chemotherapy for previous treatment of breast cancer; bilateral mastectomy; active and known drug dependence, including alcoholism; history of positivity for the hepatitis B surface antigen, hepatitis C virus or HIV; woman in breastfeeding phase; a woman of childbearing age who is not consenting to the effective Birth control methods (eg, sterilization, withdrawal, birth control pills, Depo-Provera injections or contraceptive implants) during treatment; not be available to complete all necessary procedures for study visits; history or evidence of any clinically significant condition or other disorder or illness that may hinder the evaluation of procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (Left Aorta, Left Atrium, Diastolic Diastolic Diameter of Left Ventricle, Left Diastolic Diastolic Diameter of Left Ventricle, Left Ventricle Final Diastolic Diameter, Left Ventricle Final Diastolic Diameter, Left Ventricle Final Diastolic Diastolic, Left Ventricle Final Diastolic Show, Diastolic Spectrum Left Ventricle Final, Left Ventricle Final Diastolic Show, 20 days before chemotherapy and after 3 months of chemotherapy completion. | — |
Secondary
| Measure | Time frame |
|---|---|
| troponin T (TnT), creatinine phosphokinase (CPK), creatinine, glutamic-oxalacetic transaminase (GOT), Glutamic-pyruvic transaminase (GPT), Lactic dehydrogenase (LDH) and Creatine Kinase-MB (CKMB)were evaluated by prior biochemical blood tests preconditioning and post preconditioning in each cycle and at the end of 3 to 6 months after chemotherapy. | — |
Countries
Brazil
Contacts
Public ContactSimone Meneghetti Zatta
Faculdade de Medicina do ABC (FMABC)
Outcome results
None listed