Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-26 @ 1:03 AM
Study NCT ID:
NCT04618094
Status:
UNKNOWN
Last Update Posted:
2020-11-05
First Post:
2020-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prehabilitation in Patients Suffering From Gynecological Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-04', 'studyFirstSubmitDate': '2020-10-15', 'studyFirstSubmitQcDate': '2020-11-04', 'lastUpdatePostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'adherence to the exercise intervention', 'timeFrame': '4 to 8 weeks', 'description': 'rate of completed exercise sessions as a measure of feasibility and acceptance'}], 'secondaryOutcomes': [{'measure': 'cardiovascular fitness', 'timeFrame': '4 to 8 Weeks', 'description': 'determined by VO2max'}, {'measure': 'workability', 'timeFrame': '4 to 8 weeks', 'description': 'determined by the workability index questionnaire; minimum value 7, maximum value 49, higher values indicating better results'}, {'measure': 'Health related Quality of life: questionnaire', 'timeFrame': '4 to 8 weeks', 'description': 'determined by the European Organisation for Research and Treatment of Cancer Quality of Life questionnaire, minimum value 30, maximum value 126, higher scores indicating higher quality of life'}, {'measure': 'Anxiety and depression', 'timeFrame': '4 to 8 weeks', 'description': 'determined by the Hospital Anxiety and Depression Scale questionnaire, minimum value 14, maximum value 56, higher values indicating higher depression levels'}, {'measure': 'handgrip strength', 'timeFrame': '4 to 8 weeks', 'description': 'determined by the handgrip dynamometer'}, {'measure': 'body composition', 'timeFrame': '4 to 8 weeks', 'description': 'determined by bioimpedance analysis'}, {'measure': 'Cholesterol', 'timeFrame': '4 to 8 weeks', 'description': 'Laboratory parameter in mg/ml as a part of the evaluation for cardiovascular risk factors'}, {'measure': 'Thyreoglobulin', 'timeFrame': '4 to 8 weeks', 'description': 'Laboratory parameter in µg/ml as a part of the evaluation for cardiovascular risk factors'}, {'measure': 'hemoglobin A1c', 'timeFrame': '4 to 8 weeks', 'description': 'Laboratory parameter in % as a part of the evaluation for cardiovascular risk factors'}, {'measure': 'Brain natriuretic peptide', 'timeFrame': '4 to 8 weeks', 'description': 'Laboratory parameter in pg/ml as a part of the evaluation for cardiovascular risk factors'}, {'measure': 'Troponin T', 'timeFrame': '4 to 8 weeks', 'description': 'Laboratory parameter in µg/ml as a part of the evaluation for cardiovascular risk factors'}, {'measure': 'Creatin Kinase', 'timeFrame': '4 to 8 weeks', 'description': 'Laboratory parameter in U/l as a part of the evaluation for cardiovascular risk factors'}, {'measure': 'C-reactive protein', 'timeFrame': '4 to 8 weeks', 'description': 'Laboratory parameter in mg/l as a part of the evaluation for inflammation'}, {'measure': 'interleukin 1', 'timeFrame': '4 to 8 Weeks', 'description': 'Laboratory parameter in ng/ml as a part of the evaluation for inflammation'}, {'measure': 'interleukin 6', 'timeFrame': '4 to 8 weeks', 'description': 'Laboratory parameter in ng/ml as a part of the evaluation for inflammation'}, {'measure': 'Tumor Necrosis Factor alpha', 'timeFrame': '4 to 8 weeks', 'description': 'Laboratory parameter in pg/ml as a part of the evaluation for inflammation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prehabilitation']}, 'descriptionModule': {'briefSummary': 'In 2016, 2216 Austrian women (= 10% of all new cancer cases) were diagnosed with gynecological tumors. Depending on stage and entity, a main primary therapy option is the surgical tumor resection. In the phase of Prehabilitation (= the time frame from diagnosis to surgical intervention) supportive therapy options such as individualized exercise interventions potentially improve recovery and postoperative outcomes after surgical interventions. The primary aim of this study is to investigate the feasibility and acceptance of a prehabilitation training intervention with high-intensity interval training compared to a conventional moderate intensity continuous training and a non-training collective. Secondary goals are the investigation of the effectiveness of threshold-based intensity prescriptions and the impact on quality of life, fatigue, anxiety, depression, sexuality and ability to work.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histopathologically verified cervical carcinoma (ICD10-C53) or\n* endometrial carcinoma (ICD10-C54) or\n* ovarian carcinoma (ICD10-C56)\n* planned primary/adjuvant surgery or medical training therapy\n* oncological release for medical training therapy\n* Eastern cooperative oncology group performance status (ECOG) 0-II\n* Age \\>18a to 80\n* mental aptitude to participate in the study\n\nExclusion Criteria:\n\n* serious orthopaedic, rheumatological, neurological, oncological and cardiovascular diseases which are incompatible with a training intervention\n* general contraindications for exercise ergometry according to the guidelines of the austrian society of cardiology\n* osseous or cerebral metastasis\n* participation in a training study in the last year or already before cancer diagnosis with high training volumes (\\>150min moderate / \\>75min more intensive endurance training per week)'}, 'identificationModule': {'nctId': 'NCT04618094', 'briefTitle': 'Prehabilitation in Patients Suffering From Gynecological Cancers', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Feasibility and Acceptance of High Intensity Interval Training in the Prehabilitation of Patients Suffering From Gynecological Cancers - a Randomized Controlled Pilot Study', 'orgStudyIdInfo': {'id': 'Prehab'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High intensity interval group', 'interventionNames': ['Other: bicycle ergometer training with different intensities']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Moderate continous intensity group', 'interventionNames': ['Other: bicycle ergometer training with different intensities']}, {'type': 'NO_INTERVENTION', 'label': 'non-exercising group'}], 'interventions': [{'name': 'bicycle ergometer training with different intensities', 'type': 'OTHER', 'description': 'Following a 10-min warm-up phase at a constant work load below ventilatory threshold, participants of the high intensity interval group perform repeated high intensity exercise bouts, followed by an active recovery on a bicycle ergometer. The comparative group perform a constant moderate intensity with the same mean workload. The cool-down phase is 5 min with a constant work load for both groups.', 'armGroupLabels': ['High intensity interval group', 'Moderate continous intensity group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Stefano Palma, MD', 'role': 'CONTACT', 'email': 'stefano.palma@meduniwien.ac.at', 'phone': '434040023080'}], 'overallOfficials': [{'name': 'Stefano Palma, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, PhD student', 'investigatorFullName': 'Stefano Palma', 'investigatorAffiliation': 'Medical University of Vienna'}}}}