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

NCT05704894 | Unknown Phase 3

• 1 other identifier: ERITROBLA1222
• Study Type: interventional
• Target: 320
• Locations: 0 countries
• Sites: N/A

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

Conditions

Anemia; Neoplasms; Chemotherapeutic-Induced Anemia

Keywords

children; anemia; chemotherapy treatment; quality of life; erythropoietin

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks (from baseline to the level at 12 weeks)

Secondary Outcomes (4)

• Need for red blood cell transfusion;

  16 weeks (weekly assessment)

• Best Quality of Life Scores;

  16 weeks (weekly assessment)

• Best Scores on the Fatigue Questionnaire;

  16 weeks (weekly assessment)

• Analysis of adverse events and side effects associated with medication.

  16 weeks (weekly assessment)

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Biological: Erythropoietin

Control Group

NO INTERVENTION

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.

Interventions

Erythropoietin BIOLOGICAL

Administration of Erythropoietin 150UI/Kg/week divided into 3 doses, IV, for a period of 12 weeks, in patients with hemoglobin between \<12g/dL

Intervention group

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Blau Farmaceutica S.A.: lead

MeSH Terms

Conditions

Anemia; Neoplasms

Interventions

Erythropoietin

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Clinical Research

  Blau Farmaceutica S.A.

  STUDY DIRECTOR

Central Study Contacts

Blau Farmacêutica

CONTACT

114615-9400; pesquisaclinica@blau.com

Research Operations

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: January 30, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: November 1, 2025
• Last Updated: January 30, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share