Cardiac Management of Patients With Thalassemia Minor and Breast Cancer

Completed

• Conditions: Breast Cancer; Heart Diseases; Thalassemia Minor

• Registration Number: NCT05960214
• Lead Sponsor: Istanbul University

Brief Summary

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.

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 Timeline

• Study Start: 2020-01-01
• Primary Completion: 2023-06-22
• Study Completion: 2023-06-30
• Status Verified: 2023-07
• Study First Submitted: 2023-07-12
• Study First Submitted QC: 2023-07-21
• Last Update Submitted: 2023-07-21
• Study First Posted: 2023-07-25
• Last Update Posted: 2023-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of any rise in troponin	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	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	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.

Trial Locations

Locations (1)

Istanbul Faculty of Medicine; 🇹🇷 Fatih, Istanbul, Turkey