Clinical trial NCT05960214: Cardiac Management of Patients With Thalassemia Minor and Breast Cancer
Official title: Management of Patients With Thalassemia Minor and Breast Cancer at CardioOncology Outpatient Clinics: Age Quod Agis (AQUA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Thalassemia Minor
Heart Diseases
Keywords: Cardiotoxicity
Cancer treatment related cardiac dysfunctions
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with breast cancer and thalassemia minor and patients with breast cancer only.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of any rise in troponin
timeFrame: From enrollment to 12 months
measure: Incidence of any rise in NT-ProBNP
timeFrame: From enrollment to 12 months
measure: Incidence of any reduction in LV
timeFrame: From enrollment to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fatih
country: Turkey
facility: Istanbul Faculty of Medicine
state: Istanbul
Study officials:
affiliation: Istanbul University
name: Cafer Zorkun, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: