Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-02-25 @ 11:04 PM
Study NCT ID:
NCT03131102
Status:
COMPLETED
Last Update Posted:
2024-04-26
First Post:
2017-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Early Tiredness (Acute Fatigue) in Patients With Epithelial Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D028361', 'term': 'Mitochondrial Diseases'}], 'ancestors': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Muscle biopsies'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-24', 'studyFirstSubmitDate': '2017-03-27', 'studyFirstSubmitQcDate': '2017-04-24', 'lastUpdatePostDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality of life', 'timeFrame': 'At baseline, hospital discharge (expected average of 14 days)', 'description': 'Assessed with EQ-5D questionnaire by the EuroQol Group'}], 'primaryOutcomes': [{'measure': 'Acute Fatigue Score (AFS)', 'timeFrame': '1 hour after the end of anaesthesia', 'description': 'Rating of the AFS'}], 'secondaryOutcomes': [{'measure': 'Acute Fatigue Score (AFS)', 'timeFrame': 'Up to the fifth postoperative day, at hospital discharge (an average of two weeks) and before and after the first cycle of chemotherapy (an average of four to six weeks)', 'description': 'Perioperative time course of the ratings of AFS'}, {'measure': 'Inter-Rater Variability of Acute Fatigue Score (AFS)', 'timeFrame': 'Up to the fifth postoperative day, at hospital discharge (an average of two weeks) and before and after the first cycle of chemotherapy (an average of four to six weeks)', 'description': 'The scores will be assessed by two observers and the variability determined'}, {'measure': 'Identity-Consequence Fatigue Scala (ICFS)', 'timeFrame': 'Up to the fifth postoperative day, at hospital discharge (an average of two weeks) and before and after the first cycle of chemotherapy (an average of four to six weeks)', 'description': 'Previously published score to measure tiredness'}, {'measure': 'Hemodynamic variables and catecholamine administration', 'timeFrame': 'Up to the fifth postoperative day', 'description': 'Hemodynamic variables are assessed by the anesthesia monitor'}, {'measure': 'Hemodynamic variables obtained by Electrical Cardiometry (EC)', 'timeFrame': 'Up to the fifth postoperative day, at hospital discharge (an average of two weeks) and before, during and after the first cycle of chemotherapy (an average of four to six weeks)', 'description': 'EC is a method of bioimpedance'}, {'measure': 'Hemodynamic shock indices calculated from Electrical Cardiometry (EC)', 'timeFrame': 'Up to the fifth postoperative day, at hospital discharge (an average of two weeks) and before, during and after the first cycle of chemotherapy (an average of four to six weeks)', 'description': 'EC is a method of bioimpedance'}, {'measure': 'Heart rate variability, cardiorespiratory coupling, pulse wave velocity and new markers calculated from raw biosignals', 'timeFrame': 'Up to the fifth postoperative day, at hospital discharge (an average of two weeks) and before, during and after the first cycle of chemotherapy (an average of four to six weeks)', 'description': 'Bioelectrical signals to assess the interaction of the cardiac and pulmonary rhythms'}, {'measure': 'Metabolomics/Proteomics', 'timeFrame': 'Up to the first postoperative day', 'description': 'Metabolomic, proteomic, immunological, endothelial and inflammatory markers obtained by intramuscular microdialysis'}, {'measure': 'Mitochondrial respiratory chain activities', 'timeFrame': 'Up to the first postoperative day', 'description': 'Respiratory chain activities are assessed in muscle biopsies using high-resolution respirometry'}, {'measure': 'Nutrition associated antibodies and deficiency states of vitamins and trace elements', 'timeFrame': 'Up to the fifth postoperative day', 'description': 'Biochemical parameters of nutrition states and immunological marker of alimentary components are determined'}, {'measure': 'Blood loss', 'timeFrame': 'Up to the fifth postoperative day', 'description': 'Perioperative blood loss characteristics'}, {'measure': 'Body temperature', 'timeFrame': 'Up to the first postoperative day', 'description': 'Body temperature will be assessed continuously and discontinuously'}, {'measure': 'Fluid balances', 'timeFrame': 'Up to the fifth postoperative day, at hospital discharge (an average of two weeks) and before, during and after the first cycle of chemotherapy (an average of four to six weeks)', 'description': 'The balances between all orally and intravenously administered fluids and all fluid losses'}, {'measure': 'Blood coagulation markers', 'timeFrame': 'Up to the fifth postoperative day', 'description': 'Parameters characterizing the humoral and cellular (thrombocytes) coagulation will be determined'}, {'measure': 'Immunologic, endothelial and hepatic markers', 'timeFrame': 'Up to the fifth postoperative day', 'description': 'Parameters characterizing the time course of immunological (e.g. Interleukin-6) and endothelial (e.g. Intercellular Adhesion Molecule 1) and hepatic (e.g. cytokeratin-18) response will be determined'}, {'measure': 'Organ dysfunctions and complications', 'timeFrame': 'Up to the fifth postoperative day, at hospital discharge (an average of two weeks) and before, during and after the first cycle of chemotherapy (an average of four to six weeks)', 'description': 'Organ complications are classified according to Clavien-Dindo classification'}, {'measure': 'Microvascular function', 'timeFrame': 'Up to the fifth postoperative day and at hospital discharge (an average of two weeks)', 'description': 'Microvascular function is assessed by near-infrared spectroscopy (NIRS) combined with a vascular occlusion test (VOT)'}, {'measure': 'Functional status', 'timeFrame': 'At baseline, hospital discharge (expected average of 14 days) and before and after the first cycle of chemotherapy (an average of four to six weeks)', 'description': 'Measured by the Barthel activities of daily living (ADL) index and activities of daily living (IADL)'}, {'measure': 'Intensive care unit length of stay', 'timeFrame': 'Participants will be followed up until intensive care unit discharge (an average of two days)', 'description': 'Time from admission to discharge from the intensive care unit'}, {'measure': 'Hospital length of stay', 'timeFrame': 'Participants will be followed up until hospital discharge (expected average of 14 days)', 'description': 'Time from admission to discharge from the hospital'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Perioperative Early Tiredness (Acute Fatigue)', 'Electrical Cardiometry', 'Biosignals', 'Mitochondrial Dysfunction', 'Nutrition']}, 'descriptionModule': {'briefSummary': 'In surgical patients early risk prediction of postoperative complications and organ dysfunctions is still an important clinical challenge whereas appropriate risk predictors are still missing. In this regard, fatigue is a complex phenomenon, is affected by many factors and has been shown to be associated with delayed return to normal activity after surgery. The investigators hypothesize that early tiredness (acute fatigue) assessed shortly after surgery is associated to postoperative complications and organ dysfunctions and might be used for risk stratification. Therefore, in this prospective, observational study the investigators introduce and evaluate a newly developed score to assess early fatigue during the perioperative period ("Acute Fatigue Score", AFS).\n\nThe AFS and the Identity-Consequence Fatigue Scala will be used to assess early fatigue and perioperative time courses and inter-rater-variability will be evaluated. The rating of these two fatigue scores will be evaluated regarding the association with hemodynamic, immunologic, endothelial, metabolic, gastrointestinal measures as well as organ dysfunction and complications after surgery.\n\nFurthermore, hemodynamic, immunologic, endothelial, metabolic and gastrointestinal measures are investigated with respect to the intraoperative course and postoperative organ dysfunction and complications. In a subgroup of patients, patients will undergo specialized metabolic measures to investigate mitochondrial dysfunction during the perioperative period.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with epithelial ovarian cancer undergoing cytoreductive surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with epithelial ovarian cancer scheduled for cytoreductive surgery at the Department of Gynecology at Campus Virchow - Klinikum, Charité - University Berlin\n* Offered patient information and written informed consent\n\nExclusion Criteria:\n\n* Patients aged less than 18 years\n* Persons without the capacity to consent\n* Inability of German language use\n* Lacking willingness to save and hand out data within the study\n* Accommodation in an institution due to an official or judicial order\n* (Unclear) history of alcohol or substances disabuse\n* Coworker of the Charité\n* Known Myopathy\n* Neurological or psychiatric disease at the beginning of hospitalization\n* CHF (congestive heart failure) according to (New York Heart Association) classification - NYHA class IV at the beginning of hospitalization\n* American Society of Anesthesiologists (ASA) classification greater than IV\n* Renal insufficiency (dependency of haemodialysis) at the beginning of hospitalization\n* Pulmonary oedema in thorax x-ray at the beginning of hospitalization\n* History of intracranial hemorrhage within one year before participation in the study\n* Conditions following venous thrombosis within the last three years before study inclusion\n* Known allergies or hypersensitivity on colloidal, starch or gelatine infusion solutions\n* Diabetes mellitus with signs of severe neuropathy\n* Known atrial fibrillation\n* Participation in an interventional clinical trial during the study period; exception: assignment to adjuvant therapy study during this study is allowed.'}, 'identificationModule': {'nctId': 'NCT03131102', 'acronym': 'PERISCOPE', 'briefTitle': 'Perioperative Early Tiredness (Acute Fatigue) in Patients With Epithelial Ovarian Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Association of Perioperative Early Tiredness (Acute Fatigue) With Hemodynamic, Immunologic, Endothelial, Metabolic, Gastrointestinal Measures and Complications in Patients With Epithelial Ovarian Cancer', 'orgStudyIdInfo': {'id': 'PERISCOPE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with epithelial ovarian cancer (EOC)', 'description': 'Patients undergoing cytoreductive surgery due to epithelial ovarian cancer'}, {'label': 'Subgroup - Metabolomics in EOC patients without ascites', 'description': 'In a subgroup (n=10), patients without preoperative ascites will undergo extended metabolic measures to investigate mitochondrial dysfunction during the preoperative period.'}, {'label': 'Subgroup - Metabolomics in EOC patients with ascites >500ml', 'description': 'In a subgroup (n=10), patients with preoperative ascites \\>500ml will undergo extended metabolic measures to investigate mitochondrial dysfunction during the preoperative period.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow Klinikum, Charité - University Medicine Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Oliver Hunsicker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - University Medicine Berlin'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aarne Feldheiser', 'class': 'OTHER'}, 'collaborators': [{'name': 'Experimental & Clinical Research Center Berlin', 'class': 'UNKNOWN'}, {'name': 'German Institute of Human Nutrition', 'class': 'OTHER'}, {'name': 'Humboldt-Universität zu Berlin', 'class': 'OTHER'}, {'name': 'Technische Universität Berlin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Consultant', 'investigatorFullName': 'Aarne Feldheiser', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}