Cardiac Management of Patients With Thalassemia Minor and Breast Cancer

This retrospective study aimed to evaluate the demographic characteristics, clinical conditions in term of physical examination findings), functional status, and laboratory results of patients with thalassemia minor (TM) and breast cancer (BC) in order to identify any differences between the group with BC only.

Available data as anticancer treatment, comorbidities, weight and height will be combined to report body mass index (BMI) in kg/m2, systolic and diastolic blood pressure, heart rate, ECG, transthoracic echocardiography, blood count, lipid panels, glucose, kidney function tests, (N terminal) NT-proBNP, troponins, handgrip assessments, functional status were extracted from patients files and hospital electronic archives.

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Key information

Conditions

Breast Cancer Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Breast Diseases Breast Neoplasms Cardiotoxicity Cardiovascular Diseases Chemically-Induced Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Drug-Related Side Effects and Adverse Reactions Genetic Diseases, Inborn Heart Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Skin Diseases Skin and Connective Tissue Diseases Thalassemia Thalassemia Minor Wounds and Injuries beta-Thalassemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Faculty of Medicine

Fatih, Istanbul, 34093, Turkey (Türkiye)

About this study

Following data was extracted from files and hospital electronic records, and will be evaluated (at baseline, 3, 6, 9 and 12 months):

Physical examination findings (as pretibial edema, jugular venous distension, lung rales),
Clinically significant changes in cardiac function as determined by Left Ventricular Ejection Fraction (LVEF) measurements using transthoracic echocardiography,
Any changes in (N terminal) NT-ProBNP and troponin,
Any changes in manual handgrip measurements for both hands using hydraulic hand dynamometer,
Applied medications,

were extracted and will be evaluated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with diagnosis of breast cancer, and thalassemia minor,
>18 years old,
Referred by oncologist for cardiac evaluation.
Patients with available cardiac evaluations data at baseline and during breast cancer treatment

Exclusion criteria

Patients without diagnosis of breast cancer, and thalassemia minor,
<18 years old,
Patients without any cardiac evaluations at baseline, and during cancer treatment.
Patients with history of any cardiotoxic treatment prior to enrolment.

Treatment and study plan

Primary outcomes

Incidence of any rise in troponin

Time frame: From enrollment to 12 months

Troponin results from baseline and at 3, 6 and 12 months of cancer treatment .
Incidence of any rise in NT-ProBNP

Time frame: From enrollment to 12 months

NT-ProBNP results from baseline and at 3, 6 and 12 months of cancer treatment .
Incidence of any reduction in LV

Time frame: From enrollment to 12 months

Echocardiographic measurements of Left ventricle (LV) ejection fraction from baseline and at 3, 6 and 12 months of cancer treatment.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

Management of Patients With Thalassemia Minor and Breast Cancer at CardioOncology Outpatient Clinics: Age Quod Agis (AQUA)

Acronym: AQUA

Important dates

Study start: 2020
Primary completion: 2023
Study completion: 2023
First posted: Jul 25, 2023
Registry last updated: Jul 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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