Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT01106820
Status:
COMPLETED
Last Update Posted:
2016-12-19
First Post:
2010-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Progressive Resistance Training Versus Relaxation for Breast Cancer Patients During Chemotherapy: Biological Mechanisms and Effects on Fatigue and Quality of Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-16', 'studyFirstSubmitDate': '2010-04-14', 'studyFirstSubmitQcDate': '2010-04-19', 'lastUpdatePostDateStruct': {'date': '2016-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fatigue measured by Fatigue Assessment Questionnaire (FAQ)', 'timeFrame': 'change between baseline and week 13 (end of intervention)'}], 'secondaryOutcomes': [{'measure': 'Quality of Life measured by the European Organisation for Research and Treatment of Cancer questionnaire (EORTC-QLQ30/BR23)', 'timeFrame': 'change between baseline and week 13 (end of intervention)'}, {'measure': 'Depression measured by "Allgemeine Depressionsskala" (ADS, the German version of the Center for Epidemiological Studies Depression Scale (CES-D))', 'timeFrame': 'change between baseline and week 13 (end of intervention)'}, {'measure': 'Muscle strength measured at the IsoMed2000®', 'timeFrame': 'change between baseline and week 13 (end of intervention)'}, {'measure': 'Cardiorespiratory fitness measured by ergospirometry', 'timeFrame': 'change between baseline and week 13 (end of intervention)'}, {'measure': 'Biomarker in blood, urine, and saliva', 'timeFrame': 'change between baseline and week 6 and 13'}, {'measure': 'Number of patients with adverse events potentially related to the resistance training', 'timeFrame': 'during the 12-week exercise intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Cancer-related Fatigue']}, 'referencesModule': {'references': [{'pmid': '23103936', 'type': 'BACKGROUND', 'citation': 'Schmidt ME, Wiskemann J, Krakowski-Roosen H, Knicker AJ, Habermann N, Schneeweiss A, Ulrich CM, Steindorf K. Progressive resistance versus relaxation training for breast cancer patients during adjuvant chemotherapy: design and rationale of a randomized controlled trial (BEATE study). Contemp Clin Trials. 2013 Jan;34(1):117-25. doi: 10.1016/j.cct.2012.10.006. Epub 2012 Oct 25.'}, {'pmid': '25484317', 'type': 'RESULT', 'citation': 'Schmidt ME, Wiskemann J, Armbrust P, Schneeweiss A, Ulrich CM, Steindorf K. Effects of resistance exercise on fatigue and quality of life in breast cancer patients undergoing adjuvant chemotherapy: A randomized controlled trial. Int J Cancer. 2015 Jul 15;137(2):471-80. doi: 10.1002/ijc.29383. Epub 2014 Dec 16.'}, {'pmid': '24837860', 'type': 'RESULT', 'citation': 'Klassen O, Schmidt ME, Scharhag-Rosenberger F, Sorkin M, Ulrich CM, Schneeweiss A, Potthoff K, Steindorf K, Wiskemann J. Cardiorespiratory fitness in breast cancer patients undergoing adjuvant therapy. Acta Oncol. 2014 Oct;53(10):1356-65. doi: 10.3109/0284186X.2014.899435. Epub 2014 May 16.'}, {'pmid': '25711667', 'type': 'RESULT', 'citation': 'Scharhag-Rosenberger F, Kuehl R, Klassen O, Schommer K, Schmidt ME, Ulrich CM, Wiskemann J, Steindorf K. Exercise training intensity prescription in breast cancer survivors: validity of current practice and specific recommendations. J Cancer Surviv. 2015 Dec;9(4):612-9. doi: 10.1007/s11764-015-0437-z. Epub 2015 Feb 26.'}, {'pmid': '39656317', 'type': 'DERIVED', 'citation': 'Koeppel M, Steindorf K, Schmidt ME, Rosenberger F, Wiskemann J. Variability in resistance training trajectories of breast cancer patients undergoing therapy. Support Care Cancer. 2024 Dec 10;33(1):12. doi: 10.1007/s00520-024-09001-4.'}, {'pmid': '39606939', 'type': 'DERIVED', 'citation': 'Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518.'}, {'pmid': '29445858', 'type': 'DERIVED', 'citation': 'Schmidt ME, Wiskemann J, Johnson T, Habermann N, Schneeweiss A, Steindorf K. L-Thyroxine intake as a potential risk factor for the development of fatigue in breast cancer patients undergoing chemotherapy. Support Care Cancer. 2018 Aug;26(8):2561-2569. doi: 10.1007/s00520-018-4095-3. Epub 2018 Feb 14.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this randomized intervention study is to investigate the effects and biological mechanisms of a supervised 12-week progressive resistance training on fatigue and quality of life in breast cancer patients during chemotherapy. To determine the effect of the exercise itself beyond potential psychosocial effects due to attention by trainers or the group support, patients in the control group have a comparable training schedule (i.e. 60 min, twice a week, for 12 weeks) but with relaxation training (Jacobsen method).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* breast cancer patient after lumpectomy or mastectomy, stage I-III\n* adjuvant chemotherapy\n* BMI at least 18\n\nExclusion Criteria:\n\n* contraindication for exercise\n* radiotherapy during intervention period'}, 'identificationModule': {'nctId': 'NCT01106820', 'acronym': 'BEATE', 'briefTitle': 'Progressive Resistance Training Versus Relaxation for Breast Cancer Patients During Chemotherapy: Biological Mechanisms and Effects on Fatigue and Quality of Life', 'organization': {'class': 'OTHER', 'fullName': 'German Cancer Research Center'}, 'officialTitle': 'Progressive Resistance Training vs. Relaxation for Breast Cancer Patients During Chemotherapy: A Randomized Controlled Intervention Trial to Evaluate the Biological Mechanisms and Effects of Resistance Training on Fatigue and Quality of Life', 'orgStudyIdInfo': {'id': 'BEATE-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Resistance training', 'interventionNames': ['Other: Supervised progressive resistance training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Relaxation training', 'interventionNames': ['Other: Supervised progressive muscle relaxation training (Jacobsen method)']}], 'interventions': [{'name': 'Supervised progressive resistance training', 'type': 'OTHER', 'description': 'Supervised progressive resistance training', 'armGroupLabels': ['Resistance training']}, {'name': 'Supervised progressive muscle relaxation training (Jacobsen method)', 'type': 'OTHER', 'description': 'Supervised progressive muscle relaxation training (Jacobsen method)', 'armGroupLabels': ['Relaxation training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'German Cancer Research Center', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'overallOfficials': [{'name': 'Karen Steindorf, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NCT Heidelberg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'German Cancer Research Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Tumor Diseases, Heidelberg', 'class': 'OTHER'}, {'name': 'University Hospital Heidelberg', 'class': 'OTHER'}, {'name': 'Central Institute of Mental Health, Mannheim', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}