Cardiac Management of Patients With Thalassemia Minor and Breast Cancer (AQUA)

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Diseases; Breast Cancer; Thalassemia Minor

Detailed Description

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

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

were extracted and will be evaluated.

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• Turkey
  • Istanbul
    • Fatih, Istanbul, Turkey, 34093
      • Istanbul Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with breast cancer and thalassemia minor and patients with breast cancer only.

Description

Inclusion Criteria:

1. Patients with diagnosis of breast cancer, and thalassemia minor,
2. >18 years old,
3. Referred by oncologist for cardiac evaluation.
4. Patients with available cardiac evaluations data at baseline and during breast cancer treatment

Exclusion Criteria:

1. Patients without diagnosis of breast cancer, and thalassemia minor,
2. <18 years old,
3. Patients without any cardiac evaluations at baseline, and during cancer treatment.
4. Patients with history of any cardiotoxic treatment prior to enrolment.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
13 pts with BC+TM; Patients diagnosed with breast cancer and thalassemia minor
13 pts with BC; Patients diagnosed with breast cancer for comparison.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of any rise in troponin	Troponin results from baseline and at 3, 6 and 12 months of cancer treatment .	From enrollment to 12 months
Incidence of any rise in NT-ProBNP	NT-ProBNP results from baseline and at 3, 6 and 12 months of cancer treatment .	From enrollment to 12 months
Incidence of any reduction in LV	Echocardiographic measurements of Left ventricle (LV) ejection fraction from baseline and at 3, 6 and 12 months of cancer treatment.	From enrollment to 12 months

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Principal Investigator: Cafer Zorkun, MD PhD, Istanbul University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): June 22, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: July 12, 2023
• First Submitted That Met QC Criteria: July 21, 2023
• First Posted (Actual): July 25, 2023

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Cardiotoxicity; Cancer treatment related cardiac dysfunctions
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Skin Diseases; Neoplasms; Neoplasms by Site; Hematologic Diseases; Breast Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Heart Diseases; Breast Neoplasms; Thalassemia; beta-Thalassemia
• Other Study ID Numbers: COEXIST-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The data underlying this article cannot be shared due to privacy concerns for the individuals who participated in the study. However, after obtaining proper permission from the IRB (Institutional Review Board), a summary of the data at the aggregate level, without individual identifiers, will be made available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No