Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-27 @ 6:48 AM
Study NCT ID:
NCT01645150
Status:
COMPLETED
Last Update Posted:
2016-03-22
First Post:
2012-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduction of Cancer Related Fatigue in Patients During TKI Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-21', 'studyFirstSubmitDate': '2012-06-11', 'studyFirstSubmitQcDate': '2012-07-19', 'lastUpdatePostDateStruct': {'date': '2016-03-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in cancer related fatigue', 'timeFrame': 'From baseline to the 6th and 12th week of training.', 'description': 'Assessed via the Multidimensional Fatigue Inventory (MFI).'}], 'secondaryOutcomes': [{'measure': 'Change in muscle strength of the knee extensor, hip flexor and forearm flexor muscles.', 'timeFrame': 'From baseline to the 12th week of training.', 'description': 'Assessed isokinetically and isometrically via an IsoMed2000 test system.'}, {'measure': 'Change in endurance capacity', 'timeFrame': 'From baseline to the 12th week of training.', 'description': 'Maximal oxygen uptake (VO2max) assessed in a maximal incremental cycling test.'}, {'measure': 'Change in body composition', 'timeFrame': 'From baseline to the 12th week of training', 'description': 'Assessed via bio-impedance measurement.'}, {'measure': 'Change in quality of life', 'timeFrame': 'From baseline to the 6th and 12th week of training.', 'description': 'Assessed via the EORTC QLQ C30.'}, {'measure': 'Change in depression', 'timeFrame': 'From baseline to the 6th and 12th week of training.', 'description': 'Assessed via "Allgemeine Depressionsskala" (ADS).'}, {'measure': 'Time of the first tumor progression under TKI therapy', 'timeFrame': 'Within the first 6 months of TKI therapy'}, {'measure': 'Time of reduction or replacement of TKI therapy', 'timeFrame': 'Within the first 6 months of TKI therapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['physical activity', 'exercise', 'training', 'fatigue', 'cancer', 'TKI', 'tyrosine kinase inhibitor'], 'conditions': ['All Tumor Entities Treated With TKI Therapy']}, 'referencesModule': {'references': [{'pmid': '28667563', 'type': 'DERIVED', 'citation': 'Rosenberger F, Wiskemann J, Vallet S, Haag GM, Schembri E, Jager D, Grullich C. Resistance training as supportive measure in advanced cancer patients undergoing TKI therapy-a controlled feasibility trial. Support Care Cancer. 2017 Dec;25(12):3655-3664. doi: 10.1007/s00520-017-3788-3. Epub 2017 Jun 30.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this pilot study is to determine the effects of a 12-week resistance training program on cancer related fatigue in cancer patients receiving tyrosine kinase inhibitor (TKI) therapy. It is hypothesized that incidence and severity of cancer related fatigue can be reduced by exercise training in this population which leads to an improved treatment completion rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female cancer patients\n* Prior to tyrosine kinase inhibitor therapy (any substance, any line)\n* Age: at least 18 yrs\n* Body mass index (BMI): at least 18 kg/m2\n* ECOG performance status: at most 2\n* Must be able to meet the requirements of the study protocol\n\nExclusion Criteria:\n\n* Acute infectious diseases\n* No ambulatory ability\n* Severe neurological disorders\n* Severe cardiovascular diseases\n* Severe pulmonary insufficiency\n* Severe renal insufficiency\n* Other current tumor diseases\n* Conditions rendering compliance impossible\n* Participation in regular strength training'}, 'identificationModule': {'nctId': 'NCT01645150', 'acronym': 'RECAP', 'briefTitle': 'Reduction of Cancer Related Fatigue in Patients During TKI Therapy', 'organization': {'class': 'OTHER', 'fullName': 'German Cancer Research Center'}, 'officialTitle': 'Pilot Study on the Effects of Strength Training on Cancer Related Fatigue in Cancer Patients During Tyrosine Kinase Inhibitor Therapy', 'orgStudyIdInfo': {'id': 'S-154/2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Strength training group', 'description': '12 weeks of progressive strength training', 'interventionNames': ['Behavioral: Progressive strength training']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'No intervention'}], 'interventions': [{'name': 'Progressive strength training', 'type': 'BEHAVIORAL', 'description': '12 weeks of supervised progressive strength training', 'armGroupLabels': ['Strength training group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'National Center for Tumor Diseases Heidelberg (German Cancer Research Center/University Hospital Heidelberg)', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'overallOfficials': [{'name': 'Carsten Grüllich, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Center for Tumor Diseases Heidelberg (GermanCRC/University Hospital Heidelberg) Germany'}, {'name': 'Friederike Scharhag-Rosenberger, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Center for Tumor Diseases Heidelberg (GermanCRC/University Hospital Heidelberg) Germany'}, {'name': 'Joachim Wiskamann, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Center for Tumor Diseases Heidelberg (GermanCRC/University Hospital Heidelberg) Germany'}, {'name': 'Dirk Jäger, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'National Center for Tumor Diseases Heidelberg (GermanCRC/University Hospital Heidelberg) Germany'}, {'name': 'Karen Steindorf, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'National Center for Tumor Diseases Heidelberg (GermanCRC/University Hospital Heidelberg) Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'German Cancer Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}