Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-26 @ 1:38 PM
Study NCT ID:
NCT06049693
Status:
COMPLETED
Last Update Posted:
2024-03-29
First Post:
2023-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iron Prehabilitation in Endometrial Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C011819', 'term': 'ferrous gluconate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-28', 'studyFirstSubmitDate': '2023-04-25', 'studyFirstSubmitQcDate': '2023-09-17', 'lastUpdatePostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with surgical site infection', 'timeFrame': 'Postoperatively (up to 30 days)', 'description': 'Participants will be followed-up to determine the incidence of postoperative surgical site infection'}, {'measure': 'Required blood transfusions per participant and aggregated mean differences', 'timeFrame': 'Perioperatively (up to 10 days)', 'description': 'The number of perioperative (intraoperative and postoperative) blood transfusions per patient will be monitored and compared among the two groups.'}], 'secondaryOutcomes': [{'measure': 'Number of participants with other postoperative infections', 'timeFrame': 'Postoperatively (up to 30 days)', 'description': 'Participants will be followed-up to determine the incidence of other postoperative infectious morbidity (other than surgical site infection)'}, {'measure': 'Duration of hospitalization per participant', 'timeFrame': 'Postoperatively (until patient exit) up to 30 days', 'description': 'The duration of hospitalization per participant will be monitored.'}, {'measure': 'Onset of adjuvant treatment per participant', 'timeFrame': 'Postoperatively up to 24 weeks', 'description': 'The interval between surgery and adjuvant treatment will be monitored.'}, {'measure': 'Survival rates of included participants', 'timeFrame': 'Postoperatively (at 3 years postoperatively)', 'description': 'Patients will be screened for recurrence of disease and their survival status will be screened at 3 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endometrial Cancer', 'Perioperative Complication', 'Prehabilitation']}, 'referencesModule': {'references': [{'pmid': '36167367', 'type': 'BACKGROUND', '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.'}, {'pmid': '30930213', 'type': 'BACKGROUND', '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.'}, {'pmid': '35771891', 'type': 'BACKGROUND', '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.'}, {'pmid': '35895618', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nAs 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.\n\nSurgical 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.\n\nIn 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Women with endometrial cancer will be recruited', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nWomen with endometrial cancer enrolled in the surgical list\n\nExclusion Criteria:\n\nWomen with endometrial cancer requiring immediate surgery due to life-threatening hemorrhage'}, 'identificationModule': {'nctId': 'NCT06049693', 'acronym': 'IROGYN', 'briefTitle': 'Iron Prehabilitation in Endometrial Cancer', 'organization': {'class': 'OTHER', 'fullName': 'National and Kapodistrian University of Athens'}, 'officialTitle': 'Iron Prehabilitation and Perioperative Infectious Diseases of Endometrial Cancer Patients', 'orgStudyIdInfo': {'id': '129/20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Iron supplementation', 'description': 'Iron supplementation will be provided in the form of ferrous gluconate 300mg twice a day for a period of 1 month', 'interventionNames': ['Drug: Ferrous Gluconate 300 MG']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control patients will be recruited on the ground of no form of iron prehabilitation'}], 'interventions': [{'name': 'Ferrous Gluconate 300 MG', 'type': 'DRUG', 'description': 'Ferrous Gluconate 300 MG twice a day', 'armGroupLabels': ['Iron supplementation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11523', 'city': 'Athens', 'country': 'Greece', 'facility': 'First department of Obstetrics and Gynecology', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'IPD will be shared upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National and Kapodistrian University of Athens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Obstetrics and Gynecology', 'investigatorFullName': 'Nikolaos Thomakos', 'investigatorAffiliation': 'National and Kapodistrian University of Athens'}}}}