Not Yet RecruitingPhase 3

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

Canada200 participantsStarted 2024-02-29

Plain-language 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

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. 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.

Exclusion criteria

What they're measuring

Maintenance of Hgb>100g/L (Hemoglobin)

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

Safety of IV iron

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

Efficiency of IV iron

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

Time to response

Timeframe: 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

Timeframe: Throughout study completion, up to 3 years.

Change in QOL (quality of Life)

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

Trial details

NCT IDNCT06248749

SponsorUniversity of Saskatchewan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-01

Contact for this trial

Maryam Al-Hayki

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

View on ClinicalTrials.gov More Anaemia in Ovarian Carcinoma trials

Plain-language summary

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. 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.

Exclusion criteria

What they're measuring

Maintenance of Hgb>100g/L (Hemoglobin)

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

Safety of IV iron

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

Efficiency of IV iron

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

Time to response

Timeframe: 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

Timeframe: Throughout study completion, up to 3 years.

Change in QOL (quality of Life)

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