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

Neoplasms Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05704894
• Other study ID #: ERITROBLA1222
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 2023
• Est. completion date: November 2025

Study information

• Verified date: December 2022
• Source: Blau Farmaceutica S.A.
• Contact: Blau Farmacêutica
• Phone: 114615-9400
• Email: pesquisaclinica[@]blau.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 320
• Est. completion date: November 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Blau Farmaceutica S.A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Need for red blood cell transfusion;	Requirement of blood cell transfusion will be assessed as number of units received on a weekly basis	16 weeks (weekly assessment)
Secondary	Best Quality of Life Scores;	We will apply the POQOLS (Pediatric Oncology Quality of Life Scale) and the PedsQL TM Multidimensional Fatigue Scale, both validated for pediatric population and in Portuguese language. The POQOLS includes 21 items distributed in three dimensions, which include "physical function and normal activities restriction" (09 items), "emotional problems" (07 items), and "response to active medical treatment" (05 items). Each answer is given on an ordinal scale of 7 points ranging from "never" to "very often". The resulting total score is given on a scale, and higher values mean lower quality of life.	16 weeks (weekly assessment)
Secondary	Best Scores on the Fatigue Questionnaire;	We will apply the POQOLS (Pediatric Oncology Quality of Life Scale) and the PedsQL TM Multidimensional Fatigue Scale, both validated for pediatric population and in Portuguese language. The PedsQL TM Multidimensional Fatigue Scale items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so that higher PedsQL Multidimensional Fatigue Scale scores indicate fewer symptoms of fatigue.	16 weeks (weekly assessment)
Secondary	Analysis of adverse events and side effects associated with medication.	Adverse events will be monitored from the time the participant gives informed consent and up to 30 days after the last dose of study medication. Adverse events will be classified according to their severity and causality, being reported to the sponsor according to regulatory deadlines.	16 weeks (weekly assessment)