Abstract | BACKGROUND: 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: 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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Authors | Andrea Zuccarini, Daniela Cicognini, Richard Tancredi, Alessandra Ferrari, Gianpiero Rizzo, Angioletta Lasagna, Riccardo Caccialanza, Luigi Cavanna, Elena Orlandi, Claudia Biasini, Peppina Molinaro, Danula Garigliano, Angela Costantino, Mauro Moroni, Lorenzo Perrone, Niccolò Leandro Alessio, Bianca Rovati, Virginia Valeria Ferretti, Catherine Klersy, Paolo Pedrazzoli |
Journal | Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer
(Support Care Cancer)
Vol. 30
Issue 9
Pg. 7645-7653
(Sep 2022)
ISSN: 1433-7339 [Electronic] Germany |
PMID | 35678882
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Copyright | © 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature. |
Chemical References |
- Ferric Compounds
- Hematinics
- sucrosomial iron
- Iron
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Topics |
- Anemia
(chemically induced, drug therapy)
- Ferric Compounds
- Hematinics
(therapeutic use)
- Humans
- Iron
(therapeutic use)
- Neoplasms
(drug therapy)
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