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

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

NCT ID: NCT05704894

Condition: Anemia
Neoplasms
Chemotherapeutic-Induced Anemia

Conditions: Official terms:
Anemia
Epoetin Alfa

Conditions: Keywords:
children
anemia
chemotherapy treatment
quality of life
erythropoietin

Study type: Interventional

Study phase: Phase 3

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention 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.

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: Erythropoietin
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
Arm group label: Intervention group

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

Criteria for 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.

Gender: All

Minimum age: 2 Years

Maximum age: 17 Years

Healthy volunteers: No

Start date: May 2023

Completion date: November 2025

Lead sponsor:
Agency: Blau Farmaceutica S.A.
Agency class: Industry

Source: Blau Farmaceutica S.A.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05704894