Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT06270667
Status:
RECRUITING
Last Update Posted:
2024-03-22
First Post:
2024-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Exercise Training in Survivors of Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D066126', 'term': 'Cardiotoxicity'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 280}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2028-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-20', 'studyFirstSubmitDate': '2024-01-19', 'studyFirstSubmitQcDate': '2024-02-13', 'lastUpdatePostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Muscle genome-wide DNA methylation and gene expression', 'timeFrame': 'Baseline, five months from baseline (i.e. end of intervention)', 'description': 'Will be assessed in Norway only. For a sub-group of participants, muscle biopsies will be further processed for RNA and DNA'}, {'measure': 'Adverse events', 'timeFrame': 'Five months from baseline (i.e. end of intervention)', 'description': 'Medical records and Patient reported outcome version of the Common Terminology Criteria for Adverse Events.'}], 'primaryOutcomes': [{'measure': 'VO2peak', 'timeFrame': 'Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline', 'description': 'Peak oxygen uptake during a treadmill-based cardiopulmonary exercise test'}], 'secondaryOutcomes': [{'measure': 'Systolic- and diastolic heart chamber dimensions', 'timeFrame': 'Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline', 'description': 'Cardiac morphology and function will be assessed by echocardiography (2D and 3D echocardiography and 2D strain echocardiography)'}, {'measure': 'Systolic- and diastolic longitudinal strain', 'timeFrame': 'Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline', 'description': 'Cardiac morphology and function will be assessed by echocardiography (2D and 3D echocardiography and 2D strain echocardiography)'}, {'measure': 'Lean body mass', 'timeFrame': 'Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline', 'description': 'Body composition will be assessed by dual x-ray absorptiometry'}, {'measure': 'Fat mass', 'timeFrame': 'Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline', 'description': 'Body composition will be assessed by dual x-ray absorptiometry'}, {'measure': 'Forced Vital Capacity', 'timeFrame': 'Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline', 'description': 'Lung function are assessed with spirometry.'}, {'measure': 'Forced Expiratory Volume 1 sec', 'timeFrame': 'Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline', 'description': 'Lung function are assessed with spirometry.'}, {'measure': 'Maximal voluntary ventilation', 'timeFrame': 'Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline', 'description': 'Lung function are assessed with spirometry.'}, {'measure': 'Diffusion capacity', 'timeFrame': 'Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline', 'description': 'Diffusion capacity for carbon monoxide is assessed with single breath diffusion capacity test.'}, {'measure': 'Physical activity', 'timeFrame': 'Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline', 'description': 'Actigraph accelerometer with physical activity diary. 7 days consecutive measurement at each timepoints.'}, {'measure': 'Physical activity', 'timeFrame': 'Baseline, 10-12 weeks from baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline', 'description': 'Patient reported physical activity is assessed with Godin Leisure-Time Exercise Questionnaire'}, {'measure': 'Global Health related Quality of life', 'timeFrame': 'Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline', 'description': 'Patient reported health related quality of life will be assessed with EORTC QLQ C 30'}, {'measure': 'Blood volume', 'timeFrame': 'Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline', 'description': 'Will be assessed in Norway only. Using the carbon monoxide rebreathing method.'}, {'measure': 'Muscle fiber area', 'timeFrame': 'Baseline, five months from baseline (i.e. end of intervention)', 'description': 'Will be assessed in Norway only. Change in muscle morphology will be assessed in muscle biopsies using immunohistochemistry'}, {'measure': 'Muscle fiber type', 'timeFrame': 'Baseline, five months from baseline (i.e. end of intervention)', 'description': 'Will be assessed in Norway only. Change in muscle morphology will be assessed in muscle biopsies using immunohistochemistry'}, {'measure': 'Muscle mitochondria mass', 'timeFrame': 'Baseline, five months from baseline (i.e. end of intervention)', 'description': 'Will be assessed in Norway only. Change in mitochondrial proteins will be assessed in muscle biopsies using western blot'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lymphoma', 'Physical Exercise', 'Cardiotoxicity', 'Cardiovascular Diseases', 'Chemotherapeutic Toxicity']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the effects of aerobic exercise with or without addition of resistance exercise to usual care in individuals treated with anthracyclines for lymphomas and to compare exercise effects to age- and sex-matched individuals with no prior history of malignant diseases.', 'detailedDescription': 'In this study, a comparison of the exercise effects between individuals previously treated for specific lymphoma diagnoses and individuals with no history of cancer will be conducted. Therefore, in addition to a randomized controlled trial in individuals with a previous lymphoma diagnosis (i.e., exercise groups and a non-exercising control group), a reference group comprising age- and sex-matched individuals with no history of a cancer diagnosis will also be included. Participants in the reference group will undergo the same exercise intervention as the aerobic exercise group. This study recruits through invitation only.\n\nThe primary endpoint in this study is the change in cardiorespiratory fitness, assessed as VO2peak. Secondary endpoints include common risk factors for cardiovascular disease and cardiometabolic health, other variables derived from the cardiopulmonary exercise test and lung function assessments, and muscle cellular endpoints from muscle biopsies obtained from m. vastus lateralis, in addition to patient-reported outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria Lymphoma participants:\n\n* Listed in relevant registers\n* Confirmed lymphoma diagnosis (i.e., Hodgkin lymphoma and aggressive non-Hodgkin lymphoma)\n* Completed treatment in the past two to five years without relapse or second cancer\n* Previous anthracycline treatment with or without mediastinal radiation\n* No severe cancer-related fatigue (per self-report)\n\nInclusion Criteria Lymphoma participants and non-cancer reference group:\n\n* Currently not performing \\>75 minutes/week of aerobic exercise\n* Willing and able to adhere to all study procedures.\n\nExclusion Criteria Lymphoma participants:\n\n* Relapse since diagnosis\n* A history, or current presence, of another diagnosis of invasive cancer of any kind\n\nExclusion Criteria Lymphoma participants and non-cancer reference group:\n\n* Presence of any uncontrolled- or recent cardiovascular disease\n* Has undergone heart surgery\n* Uses a pacemaker\n* Pregnancy\n* Unable to read and understand Swedish (applicable for the Swedish site only)\n* Unable to read and understand Norwegian (applicable for the Norwegian site)\n* Any physical or mental health condition restricting adherence to study protocol'}, 'identificationModule': {'nctId': 'NCT06270667', 'acronym': 'LYMfit', 'briefTitle': 'Effects of Exercise Training in Survivors of Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian School of Sport Sciences'}, 'officialTitle': 'The LYMfit Study: Exercise Training to Prevent Cardiovascular Disease in Lymphoma Survivors', 'orgStudyIdInfo': {'id': 'LYMfit'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aerobic Exercise', 'description': 'Aerobic Exercise twice weekly for 5 months.', 'interventionNames': ['Behavioral: Aerobic Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Combined Aerobic and Resistance Exercise', 'description': 'Combined Aerobic and Resistance Exercise twice weekly for 5 months.', 'interventionNames': ['Behavioral: Combined Aerobic and Resistance Exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Care', 'description': 'Standard Care, i.e no exercise intervention.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference Aerobic Exercise', 'description': 'Aerobic Exercise twice weekly for 5 months.', 'interventionNames': ['Behavioral: Aerobic Exercise']}], 'interventions': [{'name': 'Aerobic Exercise', 'type': 'BEHAVIORAL', 'description': 'Participants receive twice weekly supervised aerobic treadmill-based exercise sessions for five months. Session duration varies from 20 to 60 minutes, including warm-up, with exercise intensity ranging from 60 to 95% of peak heart rate. Maximal exercise capacity (VO2peak and peak heart rate) will be determined by the CPET performed by certified exercise physiologists at baseline.The exercise prescription will be sequenced so that the exercise intensity and -duration of each exercise varies within each week, leading to an accumulative increase in weekly exercise volume throughout the intervention. This intervention is also given to the Active Comparator group (i.e. non-cancer reference group)', 'armGroupLabels': ['Aerobic Exercise', 'Reference Aerobic Exercise']}, {'name': 'Combined Aerobic and Resistance Exercise', 'type': 'BEHAVIORAL', 'description': 'Twice weekly, supervised combined aerobic and resistance exercise sessions will be offered to participants. Participants randomized to the combined aerobic and resistance training group will follow the same aerobic exercise prescription as described for the Aerobic Exercise arm. In addition, participants in this group will perform five resistance exercises after the aerobic sessions. The resistance exercises will be leg press, knee extension, and calf rise, followed by seated row and chest press. Following familiarization, the training load will progressively increase following a linear periodization model throughout the intervention. exercise prescription will be sequenced so that the exercise intensity and -duration of each exercise varies within each week, leading to an accumulative increase in weekly exercise volume throughout the intervention. Only Lymphoma participants can be randomized to this arm.', 'armGroupLabels': ['Combined Aerobic and Resistance Exercise']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oslo', 'status': 'NOT_YET_RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Tormod S. Nilsen, PhD', 'role': 'CONTACT'}], 'facility': 'Norweigan School of Sport Sciences', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Uppsala', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Helena Igelström, PhD', 'role': 'CONTACT'}, {'name': 'Anna Henriksson, PhD', 'role': 'CONTACT', 'email': 'anna.km.henriksson@uu.se', 'phone': '709394175', 'phoneExt': '0046'}, {'name': 'Helena Igelström, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Anna Henriksson, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Helena Igelström', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'centralContacts': [{'name': 'Tormod S. Nilsen, PhD', 'role': 'CONTACT', 'email': 'tormodsn@nih.no', 'phone': '95069857', 'phoneExt': '0047'}, {'name': 'Helena Igelström, PhD', 'role': 'CONTACT', 'email': 'helena.igelstrom@neuro.uu.se', 'phone': '729999599', 'phoneExt': '0046'}], 'overallOfficials': [{'name': 'Tormod S. Nilsen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Norwegian School of Sport Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian School of Sport Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Uppsala University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, PhD', 'investigatorFullName': 'Tormod Skogstad Nilsen', 'investigatorAffiliation': 'Norwegian School of Sport Sciences'}}}}