Blau Farmaceutica S.A.
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
Anemia
Neoplasms
Chemotherapeutic-Induced Anemia
Erythropoietin
Phase 3
Study Type : | Interventional |
Estimated Enrollment : | 320 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
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. |
Actual Study Start Date : | May 2023 |
Estimated Primary Completion Date : | May 2025 |
Estimated Study Completion Date : | November 2025 |
Arm | Intervention/treatment |
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Experimental: Intervention group 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. |
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No Intervention: Control Group 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. |
Ages Eligible for Study: | 2 Years to 17 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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