Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Maryam Al-Hayki
CONTACT
Rashmi Nagaraj
CONTACT
Lead
University of Saskatchewan
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
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
