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Background: Iron supplementation improves the erythropoiesis-stimulating agents' (ESAs) response in chemotherapy-related anemia. The primary aim of our study is to assess the efficacy of sucrosomial iron, a new oral iron formulation, in cancer patients with chemotherapy-induced anemia treated with ESAs. The secondary objectives included the efficacy into two subgroups of patients (iron replete and functional iron deficiency) between the two study arms, safety and the effect on transfusion need.
Methods: In this randomized, multicentre, open-label, phase III clinical trial, 60 cancer patients were enrolled. Each patient was randomly assigned (1:1) to receive 12 weeks of oral sucrosomial iron at the dose of 30 mg daily in combination with ESAs or no supplementation to ESA treatment. The endpoint considered for efficacy was the proportion of patients achieving complete hematological response at 12 weeks (increase in Hb > 2 g/dL from baseline, without RBC transfusions in the previous 28 days or achieving Hb ≥ 12 g/dL).
Results: There was a statistically significant association between oral sucrosomial iron supplementation in combination with ESAs and the achievement of a complete hematological response. This response was achieved within 12 weeks by 31% of patients in the control group and by 52% of patients supplemented with oral sucrosomial iron. A trend of greater response in sucrosomial iron arm was found in both subgroups. No difference was observed about safety and transfusion need.
Conclusions: Sucrosomial iron is well tolerated and its combination with ESAs improves the hematological response in cancer patients with chemotherapy-related anemia.
Trial Registration Number And Date Of Registration: This study has been reviewed by the Institutional Ethics Committee of the IRCCS Policlinico San Matteo Foundation, Pavia, Italy (28/04/2015; prot. N. 20,150,002,059), and by the Institutional Ethics Committee of the other Italian oncological centers involved in this study.
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http://dx.doi.org/10.1007/s00520-022-07184-2 | DOI Listing |
Mediterr J Hematol Infect Dis
November 2024
Department of Pediatrics, Democritus University of Thrace, University General Hospital of Alexandroupolis, Thrace, Greece.
Background: Iron deficiency anemia (IDA) is a major public health problem among children worldwide. Iron deficiency without anemia (IDWA) is at least twice as common as IDA. Some studies propose that oral iron fortification can modify the infant's gut microbiome, leading to intestinal inflammation.
View Article and Find Full Text PDFHealthcare (Basel)
May 2024
Department of Pediatrics, Faculty of Medicine, Ege University, Children's Hospital, 35100 Izmir, Turkey.
To evaluate using different iron preparations for iron deficiency and/or iron deficiency anemia prophylaxis in infants and their iron status. In this study, we retrospectively evaluated the electronic patient records of 651 healthy children aged 9 to 13 months who met the inclusion criteria and who were followed up in pediatric follow-up outpatient clinics between January 2023 and June 2023. A total of 651 children with a mean age of 11.
View Article and Find Full Text PDFDaru
December 2024
Department of Pharmacology, School of Pharmacy, RK University, Rajkot, 360020, Gujarat, India.
Background: Anemia affects one-fourth of the world's population and is caused mostly by iron deficiency. Iron supplementation is the most essential strategy for preventing iron deficiency anemia. Conventional oral iron salts have many drawbacks such as poor absorption & bioavailability, and poor tolerability resulting in poor clinical outcomes.
View Article and Find Full Text PDFHaematologica
September 2024
Lady Davis Institute for Medical Research, Jewish General Hospital, and Department of Medicine, McGill University, Montreal, Quebec.
Iron-deficiency anemia and pre-anemic iron deficiency are the most frequent pathologies. The first line of treatment involves oral iron supplementation. The simplest, least expensive, and most commonly prescribed drug is ferrous sulfate, while other ferrous salts and ferric complexes with polysaccharides or succinylated milk proteins are also widely used.
View Article and Find Full Text PDFTransfus Med Hemother
August 2023
Department of Blood Group Serology and Transfusion Medicine, Medical University of Graz, Graz, Austria.
Introduction: Regular whole blood donors often suffer from iron deficiency (ID) or iron deficiency anemia due to the loss of 200-300 mg of iron with each donation. Hemoglobin (Hb) as donor eligibility criterion reflects iron stores only poorly. ID in blood donors is typically prevented or treated with orally administered ferrous salts, which frequently cause gastrointestinal side effects.
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