Cardiac Management of Patients With Thalassemia Minor and Breast Cancer

Breast Cancer Clinical Trial

— AQUA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05960214
• Other study ID #: COEXIST-3
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2023
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 30, 2023
• Est. primary completion date: June 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• beta-Thalassemia
• Breast Cancer
• Breast Neoplasms
• Heart Diseases
• Thalassemia

Locations

Country	Name	City	State
Turkey	Istanbul Faculty of Medicine	Fatih	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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