Open randomized trial of the application of remote ischemic preconditioning in breast cancer patients undergoing chemotherapy.

Not Applicable

Active, not recruiting

• Conditions: breast neoplasms, anthracyclines, adjuvant chemotherapy.; C04.588.180; D02.455.426.559.847.562.050; E02.186.170

• Registration Number: RBR-4pn2wb
• Lead Sponsor: Faculdade de Medicina do ABC (FMABC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-24
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Female
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
(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,<br>20 days before chemotherapy and after 3 months of chemotherapy completion.

Secondary Outcome Measures

Name	Time	Method
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.