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Prevention of Chemotherapy Induced Cardiotoxicity in Children With Bone Tumors and Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT03389724
Recruitment Status : Recruiting
First Posted : January 4, 2018
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Children's Cancer Hospital Egypt 57357

Brief Summary:
Prevention and early detection of chemotherapy-induced cardiotoxicity in children with bone tumors and Acute Myeloid Leukemia by giving capoten

Condition or disease Intervention/treatment Phase
Cardiotoxicity Acute Myeloid Leukemia in Children Bone Tumor Drug: Capoten® Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
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)
Primary Purpose: Prevention
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


Arm Intervention/treatment
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.
Drug: Capoten®
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.



Primary Outcome Measures :
  1. 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.


  2. 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.

  3. 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



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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All Acute Myeloid Leukemia and Bone Tumors patients (Osteosarcoma and Ewing's Sarcoma) who didn't receive chemotherapy will be included in the study.
  • Written Informed Consent from parents/guardian

Exclusion Criteria:

  • Patients who received chemotherapy before starting of the study
  • Patients with history of cardiac impairment, (existing or congenital heart disease).
  • Patients who show intolerance or contra-indications to ACE-I.
  • Patients developing acute (< 2 weeks) cardiotoxicity after the first high-dose chemotherapy (HDC) course.

Information from the National Library of Medicine

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


Contacts
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Contact: Doaa Albeltagi, Bph 01122553556 ext 7209 doaa.albeltagi@57357.org

Locations
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Egypt
Children's Cancer Hospital Egypt 57357 Cairo, Egypt Recruiting
Cairo, Egypt
Sponsors and Collaborators
Children's Cancer Hospital Egypt 57357
Investigators
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Principal Investigator: Zeniab salah, MD Children's Cancer Hospital Egypt 57357 Cairo, Egypt

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Responsible Party: Children's Cancer Hospital Egypt 57357
ClinicalTrials.gov Identifier: NCT03389724     History of Changes
Other Study ID Numbers: CCHE -AML0001
First Posted: January 4, 2018    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Cardiotoxicity
Bone Neoplasms
Neoplasms by Histologic Type
Neoplasms
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Captopril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents