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Asses the Impact of Early Starting Erythropoetin in the Reduction of Transfusions Blood in Childrens

Primary Purpose

Anemia, Neoplasms, Chemotherapeutic-Induced Anemia

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Erythropoietin
Sponsored by
Blau Farmaceutica S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring children, anemia, chemotherapy treatment, quality of life, erythropoietin

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Children between 2-17 years old Hemoglobin <12g/dL Solid tumors without bone metastasis Being on current chemotherapy treatment Adequate serum levels of iron, folic acid and Vitamin B12 Signature of the Free and Informed Consent Form by the person responsible and Term of Assent by the patient Exclusion Criteria: Refusal to sign the Free and Informed Consent Form and/or Term of assent Estimated survival less than 12 weeks Previous adverse reactions associated with EPO Estar em uso de EPO e inibidores do fator de indução de hipóxia.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention group

    Control Group

    Arm Description

    Administration of Erythropoietin 150UI/Kg/week divided into 3 doses, IV, for a period of 12 weeks, in patients with hemoglobin between <12g/dL. Every week (1 to 12), the study medication will be administered 3 times, according to the proposed treatment, for those allocated in the intervention group. All assessments, procedures and notes must be recorded in a source document and in a CRF.

    For the control group, the procedures will be performed according to the institution's standard treatment (Vitamin B12 and folic acid). The use of Iron, Vitamin B12 and folic acid will be allowed both in the intervention arm and in the control arm. Doses should be prescribed at the physician's discretion.

    Outcomes

    Primary Outcome Measures

    hemoglobin levels
    Increase of at least 1g/dL in hemoglobin levels within 12 weeks. The main outcome will be described in absolute and relative numbers. 95% Confidence Intervals

    Secondary Outcome Measures

    Need for red blood cell transfusion;
    Requirement of blood cell transfusion will be assessed as number of units received on a weekly basis
    Best Quality of Life Scores;
    We will apply the POQOLS (Pediatric Oncology Quality of Life Scale) and the PedsQL TM Multidimensional Fatigue Scale, both validated for pediatric population and in Portuguese language. The POQOLS includes 21 items distributed in three dimensions, which include "physical function and normal activities restriction" (09 items), "emotional problems" (07 items), and "response to active medical treatment" (05 items). Each answer is given on an ordinal scale of 7 points ranging from "never" to "very often". The resulting total score is given on a scale, and higher values mean lower quality of life.
    Best Scores on the Fatigue Questionnaire;
    We will apply the POQOLS (Pediatric Oncology Quality of Life Scale) and the PedsQL TM Multidimensional Fatigue Scale, both validated for pediatric population and in Portuguese language. The PedsQL TM Multidimensional Fatigue Scale items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so that higher PedsQL Multidimensional Fatigue Scale scores indicate fewer symptoms of fatigue.
    Analysis of adverse events and side effects associated with medication.
    Adverse events will be monitored from the time the participant gives informed consent and up to 30 days after the last dose of study medication. Adverse events will be classified according to their severity and causality, being reported to the sponsor according to regulatory deadlines.

    Full Information

    First Posted
    December 8, 2022
    Last Updated
    January 27, 2023
    Sponsor
    Blau Farmaceutica S.A.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05704894
    Brief Title
    Asses the Impact of Early Starting Erythropoetin in the Reduction of Transfusions Blood in Childrens
    Official Title
    Phase III Study, Multi-center, Open, Randomized, to Assess the Impact of Early Starting Erythropoetin in the Reduction of Transfusions Blood and Improvement of Quality of Life and Fatigue in Children Under Chemotherapy Treatment.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2023 (Anticipated)
    Primary Completion Date
    May 2025 (Anticipated)
    Study Completion Date
    November 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Blau Farmaceutica S.A.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Anemia is a frequent complication among cancer patients, both as a result of the malignancy of the disease and the aggressiveness of the treatment. Regardless of the degree of anemia, cancer patients produce less erythropoietin (EPO) and, consequently, cannot compensate for the deficit in the production of red blood cells, a situation that can worsen in presence of inflammation or infection. In the pediatric oncology population, studies vary in relation to anemia treatment protocols, indications for starting treatment and even there is no robust evidence that treatment with erythropoiesis stimulators results in increased hemoglobin levels, even in mild and moderate anemia, with improvement in quality of life scores and fatigue. Therefore, the proposed study aims to test the efficacy and safety of erythropoietin therapy in the treatment of cancer-related anemia in children and adolescents aged 2 to 17 years. As a secondary objective, to evaluate the benefit of early initiation of EPO (Hb<12g/dL) in children undergoing chemotherapy in improving quality of life and reducing fatigue. For the evaluation of secondary outcomes, the Student's t test can be applied and analyzes of variance or covariance (ANOVA or ANCOVA) (with treatment group as a factor, and baseline hemoglobin level as a covariate) will be used to compare the outcomes of efficacy defined by variation (change) time point post versus baseline between 2 groups. Adjusted means ("least square means") with 95% CI will be reported. When applicable, secondary outcomes defined by continuous variables evaluated over time (3 or more instants) will be analyzed using mixed model analysis of variance for repeated measures

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anemia, Neoplasms, Chemotherapeutic-Induced Anemia
    Keywords
    children, anemia, chemotherapy treatment, quality of life, erythropoietin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    This study will be carried out in approximately 10 participating Brazilian centers. This is a multicenter, open-label, randomized, national study. Randomization will be performed in a 1:1 ratio, in which 160 participants will be allocated to the intervention arm (Erythropoietin 150UI/Kg/week, divided into 3 doses, IV) and 160 participants to the local institution's standard care arm: Iron, Vitamin B12 and Folic Acid. Doses should be prescribed at the physician's discretion. Every week (1 to 12), the study medication will be administered 3 times, according to the proposed treatment, for those allocated in the intervention group. All evaluations, procedures and notes must be recorded in a source document and in a CRF (case report form) The use of Iron, Vitamin B12 and folic acid will be allowed both in the intervention arm and in the control arm. Doses should be prescribed at the physician's discretion.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    320 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    Administration of Erythropoietin 150UI/Kg/week divided into 3 doses, IV, for a period of 12 weeks, in patients with hemoglobin between <12g/dL. Every week (1 to 12), the study medication will be administered 3 times, according to the proposed treatment, for those allocated in the intervention group. All assessments, procedures and notes must be recorded in a source document and in a CRF.
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    For the control group, the procedures will be performed according to the institution's standard treatment (Vitamin B12 and folic acid). The use of Iron, Vitamin B12 and folic acid will be allowed both in the intervention arm and in the control arm. Doses should be prescribed at the physician's discretion.
    Intervention Type
    Biological
    Intervention Name(s)
    Erythropoietin
    Intervention Description
    Administration of Erythropoietin 150UI/Kg/week divided into 3 doses, IV, for a period of 12 weeks, in patients with hemoglobin between <12g/dL
    Primary Outcome Measure Information:
    Title
    hemoglobin levels
    Description
    Increase of at least 1g/dL in hemoglobin levels within 12 weeks. The main outcome will be described in absolute and relative numbers. 95% Confidence Intervals
    Time Frame
    12 weeks (from baseline to the level at 12 weeks)
    Secondary Outcome Measure Information:
    Title
    Need for red blood cell transfusion;
    Description
    Requirement of blood cell transfusion will be assessed as number of units received on a weekly basis
    Time Frame
    16 weeks (weekly assessment)
    Title
    Best Quality of Life Scores;
    Description
    We will apply the POQOLS (Pediatric Oncology Quality of Life Scale) and the PedsQL TM Multidimensional Fatigue Scale, both validated for pediatric population and in Portuguese language. The POQOLS includes 21 items distributed in three dimensions, which include "physical function and normal activities restriction" (09 items), "emotional problems" (07 items), and "response to active medical treatment" (05 items). Each answer is given on an ordinal scale of 7 points ranging from "never" to "very often". The resulting total score is given on a scale, and higher values mean lower quality of life.
    Time Frame
    16 weeks (weekly assessment)
    Title
    Best Scores on the Fatigue Questionnaire;
    Description
    We will apply the POQOLS (Pediatric Oncology Quality of Life Scale) and the PedsQL TM Multidimensional Fatigue Scale, both validated for pediatric population and in Portuguese language. The PedsQL TM Multidimensional Fatigue Scale items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so that higher PedsQL Multidimensional Fatigue Scale scores indicate fewer symptoms of fatigue.
    Time Frame
    16 weeks (weekly assessment)
    Title
    Analysis of adverse events and side effects associated with medication.
    Description
    Adverse events will be monitored from the time the participant gives informed consent and up to 30 days after the last dose of study medication. Adverse events will be classified according to their severity and causality, being reported to the sponsor according to regulatory deadlines.
    Time Frame
    16 weeks (weekly assessment)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Children between 2-17 years old Hemoglobin <12g/dL Solid tumors without bone metastasis Being on current chemotherapy treatment Adequate serum levels of iron, folic acid and Vitamin B12 Signature of the Free and Informed Consent Form by the person responsible and Term of Assent by the patient Exclusion Criteria: Refusal to sign the Free and Informed Consent Form and/or Term of assent Estimated survival less than 12 weeks Previous adverse reactions associated with EPO Estar em uso de EPO e inibidores do fator de indução de hipóxia.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Blau Farmacêutica
    Phone
    114615-9400
    Email
    pesquisaclinica@blau.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Research Operations
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Clinical Research
    Organizational Affiliation
    Blau Farmaceutica S.A.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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