Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:35 PM
Study NCT ID:
NCT05656651
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-06
First Post:
2022-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acute Immunological Effects of Exercise in Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2022-11-13', 'studyFirstSubmitQcDate': '2022-12-12', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Natural Killer Cells', 'timeFrame': 'Change from pre Intervention to immediately after intervention and 1 hour post intervention', 'description': 'NK cells, subgroups and innate lymphoid cells'}], 'secondaryOutcomes': [{'measure': 'Subjective Quality of Life', 'timeFrame': 'Once after intervention', 'description': 'Quality of Life (EORTC QLQ-C30, questionnaire score from 0 - 100, higher score = better quality of life)'}, {'measure': 'Fatigue', 'timeFrame': 'Once after intervention', 'description': 'Fatigue (EORTC QLQ FA12 Fatigue questionnaire range 0 - 100, higher score = worse outcome)'}, {'measure': 'Nutritional status', 'timeFrame': 'Once after intervention', 'description': 'Mini Nutritional Assessment (MNA range 0 - 14 points), lower score = worse'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '40229731', 'type': 'DERIVED', 'citation': 'Deppe I, Beller R, Kiehl F, Lazzari N, Bennstein SB, Reinhardt D, Dirksen U, Gotte M. The impact of a single HIIT intervention on the mobilization of NK cells and ILCs in adolescents and young adults (AYA) undergoing cancer treatment: an interventional controlled trial. BMC Cancer. 2025 Apr 14;25(1):689. doi: 10.1186/s12885-025-14058-3.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate and compare immune response to a single exercise intervention in cancer patients and healthy age-maged individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adolescents and young adults \\>14 years of age\n* undergoing acute cancer treatment (chemotherapy)\n* signed informed consent\n\nExclusion Criteria:\n\n* Inability to follow and implement test instructions\n* medical contraindication to HIIT on cycle ergometer\n* chemotherapeutic treatment 48 h prior\n* Hb \\<8g/dl; platelets \\< 20,000/ul.'}, 'identificationModule': {'nctId': 'NCT05656651', 'acronym': 'ACTIVE', 'briefTitle': 'Acute Immunological Effects of Exercise in Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universität Duisburg-Essen'}, 'officialTitle': 'ACTIVE- Acute Effects of a Single Physical Exercise Intervention on Immune Cells and Inflammation in Cancer Patients and a Healthy Comparison Group', 'orgStudyIdInfo': {'id': 'ACTIVE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cancer patients', 'description': 'Single exercise intervention following a HIIT protocol, duration \\~20 mins', 'interventionNames': ['Behavioral: High intensity interval exercise training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy adults', 'description': 'Single exercise intervention following a HIIT protocol, duration \\~20 mins', 'interventionNames': ['Behavioral: High intensity interval exercise training']}], 'interventions': [{'name': 'High intensity interval exercise training', 'type': 'BEHAVIORAL', 'otherNames': ['HIIT, Exercise'], 'description': 'Endurance training adapted to age, resting heart rate', 'armGroupLabels': ['Cancer patients', 'Healthy adults']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45147', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'University Hospital Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}], 'overallOfficials': [{'name': 'Miriam Götte, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Essen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universität Duisburg-Essen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Miriam Götte', 'investigatorAffiliation': 'Universität Duisburg-Essen'}}}}