Iron Prehabilitation in Endometrial Cancer (IROGYN)
Primary Purpose
Endometrial Cancer, Perioperative Complication, Prehabilitation
Status
Enrolling by invitation
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
Ferrous Gluconate 300 MG
Sponsored by
About this trial
This is an interventional treatment trial for Endometrial Cancer
Eligibility Criteria
Inclusion Criteria: Women with endometrial cancer enrolled in the surgical list Exclusion Criteria: Women with endometrial cancer requiring immediate surgery due to life-threatening hemorrhage
Sites / Locations
- First department of Obstetrics and Gynecology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Iron supplementation
Control
Arm Description
Iron supplementation will be provided in the form of ferrous gluconate 300mg twice a day for a period of 1 month
Control patients will be recruited on the ground of no form of iron prehabilitation
Outcomes
Primary Outcome Measures
Number of participants with surgical site infection
Participants will be followed-up to determine the incidence of postoperative surgical site infection
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.
Secondary Outcome Measures
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)
Duration of hospitalization per participant
The duration of hospitalization per participant will be monitored.
Onset of adjuvant treatment per participant
The interval between surgery and adjuvant treatment will be monitored.
Survival rates of included participants
Patients will be screened for recurrence of disease and their survival status will be screened at 3 years
Full Information
NCT ID
NCT06049693
First Posted
April 25, 2023
Last Updated
October 16, 2023
Sponsor
National and Kapodistrian University of Athens
1. Study Identification
Unique Protocol Identification Number
NCT06049693
Brief Title
Iron Prehabilitation in Endometrial Cancer
Acronym
IROGYN
Official Title
Iron Prehabilitation and Perioperative Infectious Diseases of Endometrial Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National and Kapodistrian University of Athens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer, Perioperative Complication, Prehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Iron supplementation
Arm Type
Experimental
Arm Description
Iron supplementation will be provided in the form of ferrous gluconate 300mg twice a day for a period of 1 month
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control patients will be recruited on the ground of no form of iron prehabilitation
Intervention Type
Drug
Intervention Name(s)
Ferrous Gluconate 300 MG
Intervention Description
Ferrous Gluconate 300 MG twice a day
Primary Outcome Measure Information:
Title
Number of participants with surgical site infection
Description
Participants will be followed-up to determine the incidence of postoperative surgical site infection
Time Frame
Postoperatively (up to 30 days)
Title
Required blood transfusions per participant and aggregated mean differences
Description
The number of perioperative (intraoperative and postoperative) blood transfusions per patient will be monitored and compared among the two groups.
Time Frame
Perioperatively (up to 10 days)
Secondary Outcome Measure Information:
Title
Number of participants with other postoperative infections
Description
Participants will be followed-up to determine the incidence of other postoperative infectious morbidity (other than surgical site infection)
Time Frame
Postoperatively (up to 30 days)
Title
Duration of hospitalization per participant
Description
The duration of hospitalization per participant will be monitored.
Time Frame
Postoperatively (until patient exit) up to 30 days
Title
Onset of adjuvant treatment per participant
Description
The interval between surgery and adjuvant treatment will be monitored.
Time Frame
Postoperatively up to 24 weeks
Title
Survival rates of included participants
Description
Patients will be screened for recurrence of disease and their survival status will be screened at 3 years
Time Frame
Postoperatively (at 3 years postoperatively)
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women with endometrial cancer will be recruited
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women with endometrial cancer enrolled in the surgical list
Exclusion Criteria:
Women with endometrial cancer requiring immediate surgery due to life-threatening hemorrhage
Facility Information:
Facility Name
First department of Obstetrics and Gynecology
City
Athens
ZIP/Postal Code
11523
Country
Greece
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
IPD will be shared upon reasonable request
Citations:
PubMed Identifier
36167367
Citation
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.
Results Reference
background
PubMed Identifier
30930213
Citation
Tyan 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.
Results Reference
background
PubMed Identifier
35771891
Citation
Fung 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.
Results Reference
background
PubMed Identifier
35895618
Citation
Bath 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.
Results Reference
background
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Iron Prehabilitation in Endometrial Cancer
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