Anaemia in Ovarian Carcinoma Clinical Trial
Official title:
The Effect Of Intravenous Iron In Treating Anemia In Ovarian Cancer Patients In Saskatchewan: A Phase-III, Open-Label, Randomized Trial (IIOVS-01)
Cancer related anemia (CRA) is a common sign occurring in more than 30% of patients at diagnosis, prior to initiation of antineoplastic therapy. Anemia is known to impact survival, disease progression, treatment efficacy, and the patient's quality of life. Proinflammatory cytokines, mainly IL-6, which are released by both tumor and immune cells, play a pivotal action in CRA etiopathogenesis: they promote alterations in erythroid progenitor proliferation, erythropoietin (EPO) production, survival of circulating erythrocytes, iron balance, redox status, and energy metabolism, all of which can lead to anemia. Chronic inflammatory conditions such as cancer influences a compromised nutritional status, which in-turn may contribute to anemia. This study aims to study the role of intravenous (IV) iron infusion in the management of anemia presented in patients previously treated or currently being treated for ovarian cancer. The study aims to identify the safety and efficacy of IV iron infusion on anemia in ovarian cancer patients, and the effect on quality of life and overall survival
This is an open label, prospective, randomized [1:1] controlled, Phase III study of Iron Sucrose, Iron Gluconate or Iron Isomaltoside (Treatment group A) versus No Iron Infusion treatment (Control group B) in participants diagnosed with ovarian cancer and with iron deficiency anemia. The primary objective of the study is to assess the efficacy of iron infusion, as measured by the primary endpoint, of Group A versus Group B. The study treatment is divided into two groups (Arms): Group A: Treatment study group All patients will be treated with iron infusion for Hgb lower than 100 g/L and/or TSAT < 20%. Blood transfusion may also be given based on physician's discretion whenever indicated: 1. When Hgb level is < 70 g/L or in case of emergency and/or rapid blood loss. 2. Blood transfusion may be given to keep active treatment (chemotherapy, surgery, PARP inhibitors, hormonal, radiation) intervals as scheduled and not to exceed the maximum 4 weeks. 3. Based on current practice and NCCN guidelines, co-investigators/treating physicians are encouraged to avoid giving blood transfusion for Hgb >70g/L, provided the patient is stable and asymptomatic. 4. Blood transfusion can be combined with iron infusion. 5. Blood transfusion can be given when indicated if there is lack of response to iron infusion. Expected iron infusion response is expected at 8 weeks or less after treatment (from the preceding dose of a single IV iron order/treatment). For example, Isomatoside, monoferric is given as one dose, where iron gluconate is fractionated over 6 doses and iron sucrose is fractionated into 3 doses. Group B: Control group 1. May receive blood transfusion when Hgb level is <70 g/L or in case of emergency and/or rapid blood loss. 2. Based on current practice and NCCN guidelines, co-investigators/treating physicians are encouraged to avoid giving blood transfusion for Hgb >70 g/L, provided the patient is stable and asymptomatic. 3. The decision to give blood transfusion for Hgb >70 g/L shall be based on the treating physician's discretion: 1. symptomatic patient 2. to maintain active treatment schedule 3. to prepare the patient for surgery or an interventional procedure ;