Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-04 @ 5:31 AM
Study NCT ID:
NCT03390569
Status:
COMPLETED
Last Update Posted:
2022-04-14
First Post:
2017-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise in Patients With Glioblastoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D005910', 'term': 'Glioma'}], 'ancestors': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-12-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-13', 'studyFirstSubmitDate': '2017-09-27', 'studyFirstSubmitQcDate': '2018-01-03', 'lastUpdatePostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival', 'timeFrame': '6 months', 'description': 'Time to tumor progression, based on Response Assessment in Neuro-Oncology (RANO) criteria'}], 'secondaryOutcomes': [{'measure': 'Cognitive Decline', 'timeFrame': '3 months, 6 months, 12 months, 18 months post-treatment', 'description': 'Tests will be scored according to published criteria, converted to z-scores based on population norms, and averaged to create an overall cognitive function score. COgnitive decline will be defined as declined scores at a given time point (preservation of cognitive functions will be defined as stable or improved scores at a given time point).'}, {'measure': 'Cognitive Complaints', 'timeFrame': '3 months, 6 months, 12 months, 18 months post-treatment', 'description': 'as measured by a validated questionnaire'}, {'measure': 'Overall survival', 'timeFrame': 'Up to 18 months post-treatment', 'description': 'rate of overall survival'}, {'measure': 'Personality Changes', 'timeFrame': '3, 6, 12 and 18 months post-treatment', 'description': 'as measured by a standardized questionnaire'}, {'measure': 'Quality of Life', 'timeFrame': '3, 6, 12 and 18 months post-treatment', 'description': 'as measured by a validated questionnaire'}, {'measure': 'Mood', 'timeFrame': '3, 6, 12 and 18 months post-treatment', 'description': 'as measured by a validated questionnaire'}, {'measure': 'Interference with valued activities and interests', 'timeFrame': '3, 6, 12 and 18 months post-treatment', 'description': 'as measured by a validated questionnaire'}, {'measure': 'Sleep Quality', 'timeFrame': '3, 6, 12 and 18 months post-treatment', 'description': 'as measured by a validated questionnaire'}, {'measure': 'Physical Function', 'timeFrame': '3, 6, 12 and 18 months post-treatment', 'description': 'strength, balance, cardiovascular endurance'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GBM', 'Glioblastoma', 'Brain Cancer', 'High-Grade Glioma', 'Glioma'], 'conditions': ['Glioblastoma']}, 'descriptionModule': {'briefSummary': 'Patients with newly-diagnosed GBM will be given personalized exercise regimes during concurrent chemo-radiation and up to 3 months later. Study aims are to investigate the feasibility and preliminary efficacy of the exercise program on progression free survival. Secondary outcomes of interest include cognition, fatigue, and quality of life.', 'detailedDescription': 'Background: Glioblastoma (GBM) is the most common malignant glioma in adults, with a very poor prognosis, limited new treatment options, and neurological sequelae, including physical and cognitive decline that adversely affect quality of life (QOL). Physical activity may be an intervention that attenuates the cognitive and physical decline associated with GBM. However, few studies examine physical activity in brain tumor patients, perhaps due to challenges in trial design, measuring outcomes, and complexity of care. Aims of this work are to develop and implement an individualized exercise intervention for GBM patients to support functional independence, and to delay tumor progression and cognitive decline. Methods: GBM patients scheduled to be treated with concurrent radiation and chemotherapy will be recruited from the neuro-oncology clinic at the Princess Margaret Cancer Centre. Participants will receive an individualized, home-based exercise program that includes aerobic and resistance training, tailored to prior level of fitness, current physical status, and individual interests. They will undergo 1-hr standardized, validated assessments of physical and neurocognitive functions, mood, fatigue, and QOL, prior to radiation, and then 3, 6, 12, and 18 months later. Significance: Identifying interventions that preserve or improve mobility and cognitive function will enhance QOL and may lengthen progression-free survival in brain tumor patients. Moreover, finding ways to help patients maintain self-care will lessen the strain on the health care system (e.g., fewer hospitalizations, delayed utilization of palliative care hospice).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* newly diagnosed glioblastoma\n* fluent in English\n* scheduled to be treated with concurrent chemoradiation (or within 2 weeks of starting treatment)\n\nExclusion Criteria:\n\n* brain metastases secondary to non-central nervous system cancer\n* less than 18 years old\n* receiving treatment at a location other than the Princess Margaret Cancer Centre\n* deemed unfit to exercise by a study oncologist\n* lack of fluency in English\n* psychiatric or neurological disorders that could interfere with participation'}, 'identificationModule': {'nctId': 'NCT03390569', 'briefTitle': 'Exercise in Patients With Glioblastoma', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Does Exercise Improve Progression-free Survival in Glioblastoma? A Prospective Single Arm Intervention Trial', 'orgStudyIdInfo': {'id': '16-5922'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise in GBM', 'description': 'All patients will be assigned a three-month exercise intervention according to their own capabilities and current activity levels', 'interventionNames': ['Behavioral: Exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'otherNames': ['Fitness', 'Physiotherapy'], 'description': 'The patients meet with a registered physiotherapist and receive individualized exercise programs starting the second week of treatment, and continuing up to 3 months later.', 'armGroupLabels': ['Exercise in GBM']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Hospital, University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Kim Edelstein, PhD, C.Psych.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Toronto, University Health Network'}, {'name': 'Warren Mason, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Toronto, University Health Network'}, {'name': 'Kristin Campbell, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Cancer Society (CCS)', 'class': 'OTHER'}, {'name': 'University of Toronto', 'class': 'OTHER'}, {'name': 'McMaster University', 'class': 'OTHER'}, {'name': 'University of British Columbia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}