Prevention of Chemotherapy Induced Cardiotoxicity in Children With Bone Tumors and Acute Myeloid Leukemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03389724|
Recruitment Status : Recruiting
First Posted : January 4, 2018
Last Update Posted : March 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cardiotoxicity Acute Myeloid Leukemia in Children Bone Tumor||Drug: Capoten®||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is a prospective randomized study where all patients presenting to the CCHE with de novo diagnosis of Bone tumor (ES and OS) and AML will be randomized to receive (Intervention arm) or not to receive (Control arm) prophylactic ACE-I with the start of chemotherapy.|
|Masking:||None (Open Label)|
|Official Title:||Prevention of Chemotherapy Induced Cardiotoxicity in Children With Bone Tumors and Acute Myeloid Leukemia|
|Actual Study Start Date :||November 14, 2017|
|Estimated Primary Completion Date :||November 14, 2020|
|Estimated Study Completion Date :||February 14, 2021|
Experimental: Group capoten (Intervention arm)
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.
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)
Other Name: Captopril
No Intervention: Group standard treatment (Control arm)
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.
- 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). [ Time Frame: 3 years ]
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.
- To determine the role of Troponin I (TnI) as an early marker of cardiac toxicity [ Time Frame: 3 years ]
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.
- To measure the accuracy of other radiological techniques for early detection of cardiotoxicity like Tissue Doppler Imaging (TDI) and Speckle-tracking Echo (STE). [ Time Frame: 3 years ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03389724
|Contact: Doaa Albeltagi, Bph||01122553556 ext firstname.lastname@example.org|
|Children's Cancer Hospital Egypt 57357 Cairo, Egypt||Recruiting|
|Principal Investigator:||Zeniab salah, MD||Children's Cancer Hospital Egypt 57357 Cairo, Egypt|