Endometrial CancerPhase 4IROGYNNCT06049693
Iron Prehabilitation in Endometrial Cancer
A Phase 4 study testing Ferrous Gluconate 300 MG in people with Endometrial Cancer and Perioperative Complication, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
Endometrial cancer patients often have iron deficiency anemia before surgery, which can be effectively treated with oral iron supplementation. Anemia and blood transfusions have been previously associated with perioperative infectious diseases. Read more about this study
- Who is it for?
- Ages 18 to 79 years, women only
- Conditions the study is for
- Endometrial Cancer, Perioperative Complication, Prehabilitation
- What is being tested?
- Ferrous Gluconate 300 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jan 2023to 1 Jan 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 79 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with endometrial cancer enrolled in the surgical list
Who cannot join
- Women with endometrial cancer requiring immediate surgery due to life-threatening hemorrhage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Iron Prehabilitation and Perioperative Infectious Diseases of Endometrial Cancer Patients
Endometrial cancer patients often have iron deficiency anemia before surgery, which can be effectively treated with oral iron supplementation. Anemia and blood transfusions have been previously associated with perioperative infectious diseases. In the present study the investigators will evaluate the impact of perioperative iron supplementation on the incidence of perioperative infections.
Read the detailed description
Prehabilitation has a multimodal conception based on three fundamental pillars: improvement of the patient's physical condition, nutritional optimization and other measures such as smoking cessation and correction of anemia.
As in the case of multimodal rehabilitation protocols, the actions of prehabilitation programs have synergistic effects, that is, small changes that, by themselves, do not have clinical significance but when added up, they produce a significant improvement in the postoperative evolution of patients.
Surgical site infections (SSIs) are considered to be the most common nosocomial infections among surgical patients and constitute a heavy and potentially preventable economic burden on health care providers. Although the impact of blood transfusion on the risk of SSI remains controversial, several studies have shown that anemia and transfusion predispose to postoperative bacterial infections.
In the present study the investigators seek to evaluate the impact of per os iron prehabilitation on perioperative outcomes of endometrial cancer patients, including need for transfusion and infectious morbidity.
- Being tested
- Ferrous Gluconate 300 MG
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous Gluconate 300 MGDrug
Ferrous Gluconate 300 MG twice a day
| Study group | Role | What they receive |
|---|---|---|
| Iron supplementation | Experimental | Iron supplementation will be provided in the form of ferrous gluconate 300mg twice a day for a period of 1 month Receives: Drug: Ferrous Gluconate 300 MG |
| Control | No intervention | Control patients will be recruited on the ground of no form of iron prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with surgical site infection
Participants will be followed-up to determine the incidence of postoperative surgical site infection
Measured: Postoperatively (up to 30 days)
Required blood transfusions per participant and aggregated mean differences
The number of perioperative (intraoperative and postoperative) blood transfusions per patient will be monitored and compared among the two groups.
Measured: Perioperatively (up to 10 days)
Secondary outcomes (4)
Number of participants with other postoperative infections
Participants will be followed-up to determine the incidence of other postoperative infectious morbidity (other than surgical site infection)
Measured: Postoperatively (up to 30 days)
Duration of hospitalization per participant
The duration of hospitalization per participant will be monitored.
Measured: Postoperatively (until patient exit) up to 30 days
Onset of adjuvant treatment per participant
The interval between surgery and adjuvant treatment will be monitored.
Measured: Postoperatively up to 24 weeks
Survival rates of included participants
Patients will be screened for recurrence of disease and their survival status will be screened at 3 years
Measured: Postoperatively (at 3 years postoperatively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start1 Jan 2023
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikolaos Thomakos, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049693
- Sponsor's protocol ID
- 129/20
- Acronym
- IROGYN
- Status last verified
- Mar 2024
- First submitted
- 25 Apr 2023
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be shared upon reasonable request
Publications
Amstad G, Geiger J, Werlen L, Montavon C, Heinzelmann V. Perioperative management with ferric carboxymaltose and tranexamic acid to reduce transfusion rate in gynaecological carcinoma surgery (TRANAFER-Study): study protocol for a single-blind, monocentre, randomised trial. BMJ Open. 2022 Sep 26;12(9):e057381. doi: 10.1136/bmjopen-2021-057381.
PubMed 36167367Tyan P, Taher A, Carey E, Amdur R, Messersmith C, Robinson HN, Gu A, Vargas MV, Moawad GN. Effect of Perioperative Transfusion on Postoperative Morbidity Following Minimally Invasive Hysterectomy for Benign Indications. J Minim Invasive Gynecol. 2020 Jan;27(1):200-205. doi: 10.1016/j.jmig.2019.03.021. Epub 2019 Mar 28.
PubMed 30930213Fung PLP, Lau VNM, Ng FF, Leung WW, Mak TWC, Lee A. Perioperative changes in haemoglobin and ferritin concentrations from preoperative intravenous iron isomaltoside for iron deficiency anaemia in patients with colorectal cancer: A pilot randomised controlled trial. PLoS One. 2022 Jun 30;17(6):e0270640. doi: 10.1371/journal.pone.0270640. eCollection 2022.
PubMed 35771891Bath M, Viveiros A, Schaefer B, Klein S, Pammer LM, Wagner S, Lorenz A, Rugg C, Gasser E, Ninkovic M, Panzer M, Pertler E, Fries D, Tilg H, Weiss G, Petzer V, Ofner-Velano D, Zoller H. Impact of preoperative anemia, iron-deficiency and inflammation on survival after colorectal surgery-A retrospective cohort study. PLoS One. 2022 Jul 27;17(7):e0269309. doi: 10.1371/journal.pone.0269309. eCollection 2022.
PubMed 35895618
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Prehabilitation and Perioperative Infectious Diseases of Endometrial Cancer Patients
- ClinicalTrials.gov ID
- NCT06049693
- Acronym / sponsor ID
- IROGYN / 129/20
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 22 Sep 2023 (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.
Endometrial cancer patients often have iron deficiency anemia before surgery, which can be effectively treated with oral iron supplementation. Anemia and blood transfusions have been previously associated with perioperative infectious diseases. In the present study the investigators will evaluate the impact of perioperative iron supplementation on the incidence of perioperative infections.
Detailed description
Prehabilitation has a multimodal conception based on three fundamental pillars: improvement of the patient's physical condition, nutritional optimization and other measures such as smoking cessation and correction of anemia.
As in the case of multimodal rehabilitation protocols, the actions of prehabilitation programs have synergistic effects, that is, small changes that, by themselves, do not have clinical significance but when added up, they produce a significant improvement in the postoperative evolution of patients.
Surgical site infections (SSIs) are considered to be the most common nosocomial infections among surgical patients and constitute a heavy and potentially preventable economic burden on health care providers. Although the impact of blood transfusion on the risk of SSI remains controversial, several studies have shown that anemia and transfusion predispose to postoperative bacterial infections.
In the present study the investigators seek to evaluate the impact of per os iron prehabilitation on perioperative outcomes of endometrial cancer patients, including need for transfusion and infectious morbidity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iron supplementation | Experimental | Drug: Ferrous Gluconate 300 MGIron supplementation will be provided in the form of ferrous gluconate 300mg twice a day for a period of 1 month |
| Control | No intervention | –Control patients will be recruited on the ground of no form of iron prehabilitation |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women with endometrial cancer enrolled in the surgical list
Key exclusion criteria (1 listed)
- Women with endometrial cancer requiring immediate surgery due to life-threatening hemorrhage
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 |
|---|---|---|
| Ferrous Gluconate 300 MGFerrous Gluconate 300 MG twice a day | Drug | Iron supplementation |
Primary outcome
Number of participants with surgical site infection
Time frame: Postoperatively (up to 30 days)
Participants will be followed-up to determine the incidence of postoperative surgical site infection
Required blood transfusions per participant and aggregated mean differences
Time frame: Perioperatively (up to 10 days)
The number of perioperative (intraoperative and postoperative) blood transfusions per patient will be monitored and compared among the two groups.
4 secondary outcomes
Number of participants with other postoperative infections
Time frame: Postoperatively (up to 30 days)
Duration of hospitalization per participant
Time frame: Postoperatively (until patient exit) up to 30 days
Onset of adjuvant treatment per participant
Time frame: Postoperatively up to 24 weeks
Survival rates of included participants
Time frame: Postoperatively (at 3 years postoperatively)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Background: PubMed 36167367Amstad G, Geiger J, Werlen L, Montavon C, Heinzelmann V. Perioperative management with ferric carboxymaltose and tranexamic acid to reduce transfusion rate in gynaecological carcinoma surgery (TRANAFER-Study): study protocol for a single-blind, monocentre, randomised trial. BMJ Open. 2022 Sep 26;12(9):e057381. doi: 10.1136/bmjopen-2021-057381.
- Background: PubMed 30930213Tyan P, Taher A, Carey E, Amdur R, Messersmith C, Robinson HN, Gu A, Vargas MV, Moawad GN. Effect of Perioperative Transfusion on Postoperative Morbidity Following Minimally Invasive Hysterectomy for Benign Indications. J Minim Invasive Gynecol. 2020 Jan;27(1):200-205. doi: 10.1016/j.jmig.2019.03.021. Epub 2019 Mar 28.
- Background: PubMed 35771891Fung PLP, Lau VNM, Ng FF, Leung WW, Mak TWC, Lee A. Perioperative changes in haemoglobin and ferritin concentrations from preoperative intravenous iron isomaltoside for iron deficiency anaemia in patients with colorectal cancer: A pilot randomised controlled trial. PLoS One. 2022 Jun 30;17(6):e0270640. doi: 10.1371/journal.pone.0270640. eCollection 2022.
- Background: PubMed 35895618Bath M, Viveiros A, Schaefer B, Klein S, Pammer LM, Wagner S, Lorenz A, Rugg C, Gasser E, Ninkovic M, Panzer M, Pertler E, Fries D, Tilg H, Weiss G, Petzer V, Ofner-Velano D, Zoller H. Impact of preoperative anemia, iron-deficiency and inflammation on survival after colorectal surgery-A retrospective cohort study. PLoS One. 2022 Jul 27;17(7):e0269309. doi: 10.1371/journal.pone.0269309. eCollection 2022.
- Individual participant dataSharing planned: Undecided. IPD will be shared upon reasonable request
Related trials for Endometrial Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 3
Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line
Endometrial Cancer
RecruitingPhase 3
Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
Advanced Endometrial Carcinoma, Recurrent Endometrial Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferrous Gluconate 300 MG in people with Endometrial Cancer and Perioperative Complication, run by National and Kapodistrian University of Athens at 1 site in Greece.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with surgical site infection (time frame: Postoperatively (up to 30 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06049693, which also lists 4 linked publications.
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 29 Mar 2024.