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

NCT06248749 | Not Yet Recruiting Phase 3

• 1 other identifier: IIOVS-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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

Conditions

Anaemia in Ovarian Carcinoma

Outcome Measures

Primary Outcomes (6)

• Maintenance of Hgb>100g/L (Hemoglobin)

  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.

  every 3 weeks during treatment, then every 3 months during follow-up, up to 3 years.

• Safety of IV iron

  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.

  At every visit through study completion, up to 3 years.

• Efficiency of IV iron

  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).

  every 3 weeks during treatment, then every 3 months during follow-up, up to 3 years.

• Time to response

  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

  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.

• Delay In Chemotherapy

  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.

  Throughout study completion, up to 3 years.

• Change in QOL (quality of Life)

  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.

  At screening, then Post treatment (every 6 months) up to 3 years.

Study Arms (2)

Iron Infusion Arm

EXPERIMENTAL

Group A: Treatment study group All patients will be treated with iron infusion for Hgb lower than 100 g/L and/or TSAT \< 20%.

Drug: IV iron

No Iron Infusion

NO INTERVENTION

Group B: No iron Infusion

Interventions

IV iron DRUG

Intravenous Iron supplement

Also known as: iron isomaltoside (Monofer, Monoferric) ferric gluconate (FG) iron sucrose (IS)

Iron Infusion Arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: biological female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are eligible to be included in the study only if all of the following criteria apply:
• Age and Sex: Female participants aged 18 years or more (\>/=18 years) at the time of informed consent.
• Type of Participant: Participants who are willing and able to comply with all scheduled visits, laboratory tests, lifestyle considerations, treatment plan, and any other study procedures.
• Disease Characteristics: Histologically confirmed primary epithelial invasive ovarian cancer of any grade, including serous, mucinous, endometrioid, clear cell, transitional, squamous and carcinosarcoma. Cancer must be FIGO stage IC-IV.
• Presence of measurable disease per RECIST v1.1, as assessed by investigator and evidenced by available baseline tumor scan. At least 1 target lesion of 10mm.
• Note: Baseline Scan is defined as the last scan prior to the date of randomization.
• Patients should be eligible for active cancer treatment ECOG less or equal to 2 and life expectancy must be more than 6 months.
• Received no more than two (2) systemic lines of chemotherapy (to allow for a \~3 years follow up).
• Patients on any active cancer treatment or with history of previous chemotherapy, surgery, radiation, PARP (Poly-ADP Ribose polymerase), biologics and hormonal treatment.
• Patients on neoadjuvant, adjuvant, advanced cancer treatment.
• Perioperative patients having upfront surgery (can be randomized after frozen section) or at interval or secondary debulking surgery.
• Informed Consent: Capable of giving signed informed consent.

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Patients would not consent for IV iron infusion or blood transfusion (Example: Jehovah's Witness).
• History of known severe hypersensitivity to IV iron transfusion with the study iron products.
• Medical conditions with contraindication to IV iron infusion or blood transfusion (Example:
• iron overload, hemosiderosis, decompensated liver cirrhosis or active hepatitis.)
• Palliative patients with life expectancy 6 months or less.

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (2)

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

MeSH Terms

Interventions

ferryl iron; iron isomaltoside 1000; ferric derisomaltose; ferric gluconate; Ferric Oxide, Saccharated

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Maryam Al-Hayki

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maryam Al-Hayki

CONTACT

306 766 2213; maryam.al-hayki@saskcancer.ca

Rashmi Nagaraj

CONTACT

306 966 3374; rashmi.nagaraj@usask.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gyn Oncologist

Model Details: 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.

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 8, 2024
• Study Start: February 29, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)