Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-31 @ 8:35 AM
Study NCT ID:
NCT04704856
Status:
COMPLETED
Last Update Posted:
2023-03-24
First Post:
2020-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supervised Exercise to Promote Infiltration of NK-cells Into the Tumor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-09', 'size': 7110994, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-12-18T05:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-21', 'studyFirstSubmitDate': '2020-12-18', 'studyFirstSubmitQcDate': '2021-01-07', 'lastUpdatePostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participatient Rate', 'timeFrame': '6 weeks', 'description': 'Percentage of patient actually enrolled in the study of all patients who will be screened'}, {'measure': 'Successful Examined Biopsies Rate', 'timeFrame': '6 weeks', 'description': 'Percentage of tumor biopsies that can be examined successfully'}], 'secondaryOutcomes': [{'measure': 'Generate preliminary data', 'timeFrame': '6 weeks', 'description': 'on the potential effects of exercise on immune function (Tumor tissue will be investigated by immunohistochemistry (IHC) to assess immune cell infiltration into the tumor with a specific focus on NK-cell frequency and phenotype) assessed in the tumor and in blood.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stage I-III breastcancer', 'Neoadjuvant chemotherapy', 'Exercise', 'NK-cells'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': "'Supervised exercise to PRomote Infiltration of NK-cells into the Tumor? The objective of this feasibility study is to 1) study trial feasibility in terms of patient enrollment and the percentage of tumor biopsies that can be examined successfully, and 2) generate preliminary data on the potential effects of exercise on immune function assessed in the tumor and in blood.", 'detailedDescription': 'This is a multicenter randomized controlled feasibility trial, in which 20 women with breast cancer scheduled for neoadjuvant 2 or 3 weekly AC-T(H) chemotherapy will be randomized into a combined aerobic and resistance exercise intervention group or a usual care (no exercise) control group, during the first 6 weeks (2 or 3 cycles) of chemotherapy. Patients from the control group will receive care as usual and are requested to maintain their usual daily physical activities. In order to limit contamination (increase of exercise in the control group), non-participation and prevent dropout, the control group will be offered the same 6-week exercise intervention after the tumor biopsy has been taken after 6 weeks.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Stage I-III breastcancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* stage I-III breast cancer\n* scheduled for neoadjuvant chemotherapy with 2 or 3-weekly Adriamycin/Cyclofosfamide, followed by Paclitaxel weekly +/- trastuzumab\n* willing to undergo an additional ultrasound guided biopsy\n* ECOG-performance score ≤ 2 (able to perform basic activities of daily living such as walking or biking)\n\nExclusion Criteria:\n\n* addition of immuno- or targeted therapy at start of neoadjuvant chemotherapy\n* currently participating in structured vigorous aerobic exercise and/or resistance exercise\n\n(≥2 days per week).\n\n* cognitive disorder or severe emotional instability\n* presence of other disabling co-morbidity that might hamper physical exercise e.g. heart failure (NYHA classes 3 and 4), chronic obstructive pulmonary disease (COPD, gold 3 and 4), orthopaedic conditions and neurological disorders (e.g., hernia, paresis, amputation, active rheumatoid arthritis);\n* immunosuppressive medication (e.g. corticosteroids (other than used as part of standard chemotherapy premedication protocol), cyclosporine)\n* immunodeficiency (primary or secondary)\n* impossibility to perform an ultrasound-guided biopsy of the tumor'}, 'identificationModule': {'nctId': 'NCT04704856', 'acronym': 'SPRINT', 'briefTitle': 'Supervised Exercise to Promote Infiltration of NK-cells Into the Tumor', 'organization': {'class': 'OTHER', 'fullName': 'Amsterdam UMC, location VUmc'}, 'officialTitle': 'Supervised Exercise to Promote Infiltration of NK-cells Into the Tumor', 'orgStudyIdInfo': {'id': '2020.253 NL72539.029.20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Interventiongroup', 'description': 'Interventiongroup, undergo supervised exercise for the first 6 weeks.', 'interventionNames': ['Behavioral: Supervised exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Controlgroup', 'description': 'Controlgroup, do not undergo supervised exercise for the first 6 weeks (possibility to undergo supervised exercise after 6 weeks).'}], 'interventions': [{'name': 'Supervised exercise', 'type': 'BEHAVIORAL', 'description': 'Supervised exercise during first 6 weeks of neoadjuvant chemotherapy.', 'armGroupLabels': ['Interventiongroup']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1315RA', 'city': 'Almere Stad', 'state': 'Flevoziekenhuis', 'country': 'Netherlands', 'facility': 'Flevoziekenhuis', 'geoPoint': {'lat': 52.37025, 'lon': 5.21413}}, {'zip': '1081HV', 'city': 'Amsterdam', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'VU Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Hans van der Vliet, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Amsterdam UMC, location VUmc'}, {'name': 'Laurien Buffart, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Medical Center'}, {'name': 'Marieke ten Tusscher, MSc.', 'role': 'STUDY_CHAIR', 'affiliation': 'Amsterdam UMC, location VUmc'}, {'name': 'Susanne van der Velde, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Amsterdam UMC, location VUmc'}]}, 'ipdSharingStatementModule': {'infoTypes': ['ANALYTIC_CODE'], 'timeFrame': '01-01-2023 t/m 01-01-2025', 'ipdSharing': 'YES', 'description': 'POLARIS study (PROSPERO 2013 CRD42013003805)', 'accessCriteria': 'anonymous'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amsterdam UMC, location VUmc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Hans J. van der Vliet, MD, PhD', 'investigatorAffiliation': 'Amsterdam UMC, location VUmc'}}}}