Effect of Intravenously Iron Infusion on the Prevention and Treatment of Anemia in Ovarian Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

IV iron: Intravenous Iron supplement

Study 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

Eligibility

Primary outcome measure(s)

• 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.
• 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).
• 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.
• 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.

Trial sites (2)

More University of Saskatchewan trials in Canada