Evaluation of the effects of the cardioprotective diet on prevention of the incidence of cardiotoxicity

Phase 3

Recruiting

• Conditions: C00-C97; cardiotoxicity in patients with breast cancer receiving Anthracycline.; Malignant Neoplasms

• Registration Number: IRCT20131218015860N7
• Lead Sponsor: School of Traditional Medicine, Traditional Medicine and Materia Medica Research Center,Shahid Behes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Women age 18-65
Breast cancer (based on pathology response)
Candidate for chemotherapy including anthracyclines +/- trastuzumab
25 =BMI = 19
Willingness to participate in the study

Exclusion Criteria

History of heart failure
History of coronary artery disease
Symptoms of heart failure (functional shortness of breath, orthopedics, PND)
Ejection Fraction less than or equal to 40
Use of beta-blockers or ACEI
Change the chemotherapy regimen for any reason
Unwillingness to continue the study
Follow less than 70% of trained dietary recommendations
History of liver disease (except grade 1 and 2 fatty liver)
History of kidney disease (other than history of urinary stones)
• History of depression (taking antidepressants)
BMI greater than 25 and less than 19

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eft ventricular ejection fraction. Timepoint: In weeks 0, 8 and 18 from the beginning of the intervention. Method of measurement: Echocardiography.;LV global longitudinal Strain (GLS). Timepoint: In weeks 0, 8 and 18 from the beginning of the intervention. Method of measurement: Echocardiography.

Secondary Outcome Measures

Name	Time	Method
Alteration of the cardiac marker troponin. Timepoint: Weeks 0, 8 and 18 from the beginning of the intervention. Method of measurement: blood test (Measurement of cardiac troponin enzyme). This enzyme is measured by the enzyme immunoassay method according to standard conditions with ELISA device and with a series of calibrated pipettes.;Quality of Life. Timepoint: Weeks 0, 8 and 18 from the beginning of the intervention. Method of measurement: Quality of Life Questionnaire (EORTC - QOL Br23).