Anaemia in Ovarian CarcinomaPhase 3NCT06248749
Effect of Intravenously Iron Infusion on the Prevention and Treatment of Anemia in Ovarian Cancer
A Phase 3 study testing IV iron in people with Anaemia in Ovarian Carcinoma, run by University of Saskatchewan at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anaemia in Ovarian Carcinoma
- What is being tested?
- IV iron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesCanada
- Study dates
- 29 Feb 2024to 1 Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Maryam Al-Hayki, 3067662213, maryam.al-hayki@saskcancer.ca
Maryam Al-Hayki
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
Maryam Al-Hayki, 3067662213, maryam.al-hayki@saskcancer.ca
Maryam Al-Hayki
About this study
Official title: The Effect Of Intravenous Iron In Treating Anemia In Ovarian Cancer Patients In Saskatchewan: A Phase-III, Open-Label, Randomized Trial (IIOVS-01)
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
Read the 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:
- When Hgb level is < 70 g/L or in case of emergency and/or rapid blood loss.
- 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.
- 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.
- Blood transfusion can be combined with iron infusion.
- 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
- May receive blood transfusion when Hgb level is <70 g/L or in case of emergency and/or rapid blood loss.
- 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.
- The decision to give blood transfusion for Hgb >70 g/L shall be based on the treating physician's discretion:
- symptomatic patient
- to maintain active treatment schedule
- to prepare the patient for surgery or an interventional procedure
- Conditions
- Anaemia in Ovarian Carcinoma
- Being tested
- IV iron
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV ironDrug
Also called iron isomaltoside (Monofer, Monoferric) ferric gluconate (FG) iron sucrose (IS)
Intravenous Iron supplement
| Study group | Role | What they receive |
|---|---|---|
| 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%. Receives: Drug: IV iron |
| No Iron Infusion | No intervention | Group B: No iron Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: At screening, then Post treatment (every 6 months) up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start29 Feb 2024 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anaemia in Ovarian CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maryam Al-Hayki, University of Saskatchewan
- Investigators
- Maryam Al-Hayki, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06248749
- Sponsor's protocol ID
- IIOVS-01
- Status last verified
- Feb 2024
- First submitted
- 27 Jan 2023
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Intravenous Iron In Treating Anemia In Ovarian Cancer Patients In Saskatchewan: A Phase-III, Open-Label, Randomized Trial (IIOVS-01)
- ClinicalTrials.gov ID
- NCT06248749
- Acronym / sponsor ID
- IIOVS-01
- Conditions
- Anaemia in Ovarian Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- 29 Feb 2024 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- When Hgb level is < 70 g/L or in case of emergency and/or rapid blood loss.
- 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.
- 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.
- Blood transfusion can be combined with iron infusion.
- 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
- May receive blood transfusion when Hgb level is <70 g/L or in case of emergency and/or rapid blood loss.
- 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.
- The decision to give blood transfusion for Hgb >70 g/L shall be based on the treating physician's discretion:
- symptomatic patient
- to maintain active treatment schedule
- to prepare the patient for surgery or an interventional procedure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model 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.
| Arm | Type | Receives |
|---|---|---|
| Iron Infusion Arm | Experimental | Drug: IV ironGroup A: Treatment study group All patients will be treated with iron infusion for Hgb lower than 100 g/L and/or TSAT < 20%. |
| No Iron Infusion | No intervention | –Group B: No iron Infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV ironAlso: iron isomaltoside (Monofer, Monoferric) ferric gluconate (FG) iron sucrose (IS)Intravenous Iron supplement | Drug | Iron Infusion Arm |
Primary outcome
Maintenance of Hgb>100g/L (Hemoglobin)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Anaemia in Ovarian Carcinoma
RecruitingPhase 1/2
Phase 1/2 Clinical Trial of CP-506 (HAP) in Monotherapy or With Carboplatin or ICI
Unspecified Adult Solid Tumor, Protocol Specific
Recruiting
Genetic Landscape in Women with Metastatic Ovarian Cancer Before and During Treatment with PARP Inhibitors
Leukemia, Myeloid, Acute, Myeloid Dysplasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maryam Al-Hayki principal investigator
University of Saskatchewan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IV iron in people with Anaemia in Ovarian Carcinoma, run by University of Saskatchewan at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maryam Al-Hayki (306 766 2213, maryam.al-hayki@saskcancer.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maintenance of Hgb>100g/L (Hemoglobin) (time frame: every 3 weeks during treatment, then every 3 months during follow-up, up to 3 years.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.