Effect of Intravenously Iron Infusion on the Prevention and Treatment of Anemia in Ovarian Cancer
- Registration Number
- NCT06248749
- Lead Sponsor
- University of Saskatchewan
- Brief Summary
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
- Detailed Description
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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Iron Infusion Arm IV iron Group A: Treatment study group All patients will be treated with iron infusion for Hgb lower than 100 g/L and/or TSAT \< 20%.
- Primary Outcome Measures
Name Time Method Maintenance of Hgb>100g/L (Hemoglobin) every 3 weeks during treatment, then every 3 months during follow-up, up to 3 years. by ongoing monitoring of patient Hgb status for patients on active treatment every 3 weeks and patients in follow-up every 3 months. Effect of Iron infusion on response to chemotherapy.
Safety of IV iron At every visit through study completion, up to 3 years. Measure the safety of IV iron including type and frequency of AEs, SAEs, TEAEs, discontinuation due to AEs and outcome of AE treatment. It will be compared to AEs (including frequency, SAEs, TEAs, discontinuation due to AEs and outcome of AEs treatment) of blood transfusion and it will be compared to literature data on IV iron.
Time to response Hgb will be checked just prior to treatment and then biweekly until week 8 or whenever Hgb rises at least by 20 g/L through the treatment period, upto 3 years. Time to response will be measured in every patient treated with IV iron from the time of treatment until substantial increase in Hgb from baseline 20 g/L. Hgb will be checked just prior to IV iron and then biweekly until week 8 or whenever Hgb rises at least by 20 g/L
Delay In Chemotherapy Throughout study completion, up to 3 years. Timing of chemotherapy will be recorded and that will be compared to the standard treatment protocol. Any delay of chemotherapy schedule due to "anemia" will be flagged and recorded in all participants. These data will be compared between the two study groups.
Efficiency of IV iron every 3 weeks during treatment, then every 3 months during follow-up, up to 3 years. To assess the efficiency of IV iron, Hgb will be frequently assessed as per the study protocol. Hgb will be compared to baseline level, looking at substantial increase of Hgb of about 20 g/L increase within maximum 8 weeks (study estimated response time).
Change in QOL (quality of Life) At screening, then Post treatment (every 6 months) up to 3 years. To measure any change from baseline QOL of both study groups and compare the difference of QOL in Group A (the group receiving IV infusion to correct anemia) compared to Group B. This will be done by comparing scores on the QOL questionnaire.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Allan Blair Cancer Centre
🇨🇦Regina, Saskatchewan, Canada
Saskatoon Cancer Centre
🇨🇦Saskatoon, Saskatchewan, Canada