Clinical trial NCT05704894: 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
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Anemia
Neoplasms
Chemotherapeutic-Induced Anemia
Keywords: children
anemia
chemotherapy treatment
quality of life
erythropoietin
Lead sponsor: Blau Farmaceutica S.A.
Sponsor class: INDUSTRY
First posted: 2023-01-30
Enrollment: 320
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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


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.

Primary outcomes:
measure: hemoglobin levels
timeFrame: 12 weeks (from baseline to the level at 12 weeks)
Secondary outcomes:
measure: Need for red blood cell transfusion;
timeFrame: 16 weeks (weekly assessment)
measure: Best Quality of Life Scores;
timeFrame: 16 weeks (weekly assessment)
measure: Best Scores on the Fatigue Questionnaire;
timeFrame: 16 weeks (weekly assessment)
measure: Analysis of adverse events and side effects associated with medication.
timeFrame: 16 weeks (weekly assessment)
Other outcomes:
Locations:
Study officials:
affiliation: Blau Farmaceutica S.A.
name: Clinical Research
role: STUDY_DIRECTOR
References: