A Phase 3 interventional study of Capoten® in Cardiotoxicity, Acute Myeloid Leukemia in Children and Bone Tumor, sponsored by Children's Cancer Hospital Egypt 57357. Completed at 1 site in Egypt. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2022-11-08.
Sponsored by Children's Cancer Hospital Egypt 57357 · Phase 3, Interventional, and Prevention
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Among 12 studies in Cardiotoxicity with a site in Egypt — 4 open to participants now, 4 under way, 2 of them phase 3. Cardiotoxicity · Egypt.
Among the 12 studies in Cardiotoxicity with a site in Egypt, this one is the only one that started in 2017, is one of 3 in phase 3, and was the 1st registered.
262 studies on the registry are indexed under Cardiotoxicity; 75 are open to participants now.
Browse Cardiotoxicity studies →4 of the 12 studies in Cardiotoxicity with a site in Egypt are open now. Recruiting first, the newest first:
Ain Shams University · Sites in Egypt
Ages 1–18
Universiti Sains Malaysia · Sites in Egypt
Ages 18–65 · Women only
Tanta University · Sites in Egypt
Ages 18+ · Women only
Assiut University · Sites in Egypt
Ages 18+
A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →
Of the 51 Cardiotoxicity studies recruiting now, 38 (75%) set no upper age limit and 8 (16%) stop at 75 or younger; 7 take children under 18; 3 take healthy volunteers.
This study: 1 Year to 18 Years · all sexes · no healthy volunteers.
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12 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 5 · Phase 3 5 · Phase 4 1
First in 2017; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 245 is above the median of 93 across 137 interventional studies indexed under Cardiotoxicity.
Median enrollment 83 across the 9 interventional studies, 178 across the 3 observational. Of the 3 that completed or were terminated, 0 (0%) have results posted.
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None of the 12 has an industry lead sponsor. The 6 most frequent:
Children's Cancer Hospital Egypt 57357 is the lead sponsor of 21 studies on the registry; 5 are open to participants now.
Children's Cancer Hospital Egypt 57357 has 1 study filed under Cardiotoxicity — fewer than ten, so there is no comparison to draw.
2 of the studies in Cardiotoxicity with a site in Egypt that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07897409Universiti Sains MalaysiaThe Impact of Using Nicorandil for the Prevention of Doxorubicin-Induced Cardiotoxicity | 2027-06-01 |
| NCT06684509Assiut UniversityAtorvaststin and Cardiotoxicity in Acute Myloid Leukemia | 2027-09 |
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Among the 12 studies in Cardiotoxicity with a site in Egypt, from their registry updates:
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Prevention and early detection of chemotherapy-induced cardiotoxicity in children with bone tumors and Acute Myeloid Leukemia by giving capoten
background and rationale: Developing countries bear the greatest burden of childhood cancers as over 90% of the world's children live in these countries. More effective treatment protocols have markedly improved the outcome of childhood cancers. The 5-year overall survival for children with cancer in general has improved from about 30% in 1960s to about 80% currently. Most of current treatment protocols for childhood cancer utilize anthracyclines as an essential chemotherapeutic agent. However, the use of anthracyclines has been limited by their dose dependent cardiotoxic side-effects during and after treatment. Many survivors of anthracycline treatment have long-term problems because of myocardial damage such as impaired left ventricular contractility and cardiomyopathy, which may lead to overt heart failure and an increased risk of death.Anthracycline-induced clinical heart failure (A-CHF) is a major public health concern within the exposed population as it may not be manifested for many years and remains a lifelong threat. It is a particular problem in children treated for cancer because it is hoped that they will survive for several decades after treatment. As survival rates continue to improve, the resources needed to predict, monitor and care for survivors will also continue to increase Several risk factors have been already identified for anthracyclines induced cardiotoxicity. Among the non modifiable risk factors are age at treatment, length of survival, sex, and few genetic factors Other important risk factors include cumulative dose of anthracyclines, rate of administration, concomitant irradiation and chemotherapeutic agents Several approaches have been tried to prevent or minimize cardiotoxicity in cancer patients. Structural modifications of anthracyclines, including liposomal anthracyclines and anthracycline analogs, have been developed with the intention to minimize cardiovascular toxicity. Epirubicin and idarubicin, analogs of doxorubicin and daunorubicin, respectively, are commonly used to treat few types of cancer. The use of liposomal anthracyclines considerably reduces anthracycline cardiotoxicity but does not eliminate it. A recent meta-analysis of two studies found that the rates for both clinical and subclinical heart failure were significantly lower with liposomal anthracyclines than with conventional anthracyclines and that tumor response and overall survival rates did not differ significantly. Both studies were limited in scope because only adult women with metastatic breast cancer were included. No randomized controlled trials comparing liposomal with conventional anthracyclines in children have been published.
Observational studies have shown that prolonged infusion of anthracyclines reduces cardiotoxicity than bolus infusions. However, a randomized controlled trial reported no statistically significant differences in echocardiographic parameters up to 8 years after treatment of patients receiving either continuous infusion or bolus administration.
Dexrazoxane (the only agent proven to reduce acute cardiotoxicity in adults receiving anthracyclines) is not currently recommended in children due to raised concerns of increased incidence of secondary neoplasms.Angiotensin-Converting Enzyme Inhibitors (ACEIs) have shown marked reduction of toxic myocarditis in mouse models ( and have also shown marked decrease in adverse myocardial histopathological changes in mice treated with anthracyclines . Administration of ACEIs as a cardioprotective agent was studied in high risk cancer patients (defined by increased troponin I value) and proven to be effective . The role of ACEIs in prevention of anthracyclines induced cardiotoxicity was not examined before in a randomized controlled setting.
Proper evaluation and early prediction of cardiotoxicity necessitates a consensus on sensitive and specific monitoring methods in the pediatric population. However, several studies have addressed the rapidly evolving issue of cardiotoxicity assessment. Several cardiac biomarkers have been used to monitor and predict cardiotoxicity. Among those markers are: Cardiac Troponin T (cTnT), Cardiac Troponin I (cTnI), Atrial Natriuretic Peptide (ANP), Brain Natriuretic Peptide (BNP), N-terminal pro-BNP (NT-pro-BNP), Serum Lipid Peroxide, and Serum Carnitine. Several systematic reviews have highlighted the difficulty of assessing those biomarkers due to several limitations in performed studies and high variability. Further research is needed to establish the effectiveness of cardiac markers in children, and their link to anthracycline dose, and their use in predicting individual risk for the development and progression of cardiotoxicity .
However, more recent studies have shown that troponins are preferred due to their high sensitivity and specificity, especially when coupled with imaging modalities.
Imaging modalities for diagnosis and follow up of cardiotoxicity are the main gold standard. Echocardiogram (Doppler) is the most commonly used method due its high availability and non invasiveness. Radionuclide Angiocardiography (RNA) including MUGA have also been used. Although RNA studies exhibit lower intra-individual and intra-observer variation when obtaining and analyzing results, but only limited information regarding diastolic function is obtained. RNA's also expose patients to radiation .
A recent study has demonstrated that the use of Tissue Doppler-derived myocardial performance index is a more robust parameter in the detection of ventricular dysfunction caused by doxorubicin when compared to Doppler.
In summary, anthracyclines induced cardiotoxicity continues to be one of the most challenging problems facing children with cancer during and after treatment. No current consensus exists about the best method for early detection and monitoring of cardiotoxicity in children with cancers. Troponins, echocardiography, and tissue Doppler have shown promising results as effective modalities but they need to be further studied especially in this specific population. Several protective agents have also been tried to prevent cardiotoxicity. ACE-Inhibitors have shown promising results in adult cancer patients, but they have not been studied before in the pediatric population.
Objectives of the Study:
Aim of the Study: (Instructions: state the goal you need to achieve) Prevention and early detection of chemotherapy-induced cardiotoxicity in children with bone tumors and Acute Myeloid Leukemia.
Specific Objectives: (Instructions: state the details of each objective that will finally lead to achievement of the goal)
Secondary Objectives: (Instructions: these are subsidiary objectives that could be studied during the course of the project but are not the main objectives of the study, they are optional and vary according to the type of the study).
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Contraindication
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Patients will receive prophylactic ACE-I(Capoten®) at day 1 of initiation of chemotherapy and is to be continued for 1 year after the end of treatment. Patients will remain on this arm until they experience any of the study primary or secondary end-point where they will be off-study and will receive cardiotoxicity treatment independently.
Drug: Capoten®
Patients will not receive ACE-I as prophylaxis, and will be monitored and evaluated for first signs of cardiotoxicity based on the above mentioned end-points.
ACE-I (Capoten®) will be given to patients in the Intervention arm with the start of chemotherapy, twice daily at a dose of 0.5 mg/kg/day (divided over 2 doses)
Also known as: Captopril
To determine the effect of ACE-I in preventing chemotherapy-related cardiotoxicity using both investigation techniques: Troponin I level and cardiac imaging ( TTE, TDI, STE).
ALL patients will be subjected to the following cardiac imaging ( TTE, TDI, STE) at the each time intervals of the study. Plasma troponin I (TnI) concentration will be measured for all the patients at the each time intervals of the study.
Time frame: 3 years
To determine the role of Troponin I (TnI) as an early marker of cardiac toxicity
Troponin I (TnI) concentration is to be determined by a fluorometric enzyme immunoassay analyzer (Stratus CS, Dade Behring, Miami, Fla) with a functional sensitivity of 0.03 g/L; the cutoff level was 0.08 ng/mL. Plasma troponin I (TnI) concentration will be measured in both groupsas follows : * Early TnI: TnI concentration will be measured before and soon after each cycle of HDC. Determination of early TnI consists of a curve of assays (2ml blood sample): baseline initially, before \& after immediately, and 12 and 24 hours after the end of Anthracycline chemotherapy infusion.This sequence will be repeated with each cycle of therapy containing Anthracycline. For each patient, the highest TnI value will be considered for each chemotherapy cycle. * Late TnI: TnI value also is to be determined at the end of treatment and 2, 3, 6, and 12 months after end of treatment in both groups.
Time frame: 3 years
To measure the accuracy of other radiological techniques for early detection of cardiotoxicity like Tissue Doppler Imaging (TDI) and Speckle-tracking Echo (STE).
Patients will be evaluated Clinically for cardiac functions using ECG , conventional echo, Tissue Doppler Imaging (TDI) and SpeckelTracking Echocardiography STE , before each chemotherapy cycle maximum one week given
Time frame: 3 years
Ran from Nov 2017 to primary completion in Nov 2021, 47 months.
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Studies of the drug tested here: Captopril
Children's Cancer Hospital Egypt 57357