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Not Yet Recruiting NCT05704894

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

Conditions: Anemia, Neoplasms, Chemotherapeutic-Induced Anemia

Sex: All
Ages: 2 Years – 17 Years
Phase: PHASE3
Enrollment: 320
Sponsor: Blau Farmaceutica S.A.

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

Eligibility Criteria

Inclusion Criteria:Children between 2-17 years oldHemoglobin <12g/dLSolid tumors without bone metastasisBeing on current chemotherapy treatmentAdequate serum levels of iron, folic acid and Vitamin B12Signature of the Free and Informed Consent Form by the person responsible and Term of Assent by the patientExclusion Criteria:Refusal to sign the Free and Informed Consent Form and/or Term of assentEstimated survival less than 12 weeksPrevious adverse reactions associated with EPOEstar em uso de EPO e inibidores do fator de indução de hipóxia.

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Source: ClinicalTrials.gov (NCT05704894). StuddyBuddy aggregates publicly available trial information.