Ignite Creation Date:
2025-12-24 @ 1:34 PM
Ignite Modification Date:
2026-01-01 @ 5:02 PM
Study NCT ID:
NCT03082495
Status:
COMPLETED
Last Update Posted:
2022-05-27
First Post:
2017-02-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise During and After Neoadjuvant Rectal Cancer Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, '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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The outcome assessor will be blinded to group assignment for the clinical outcomes including treatment toxicity, treatment completion, treatment response, and surgical complications.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-24', 'studyFirstSubmitDate': '2017-02-09', 'studyFirstSubmitQcDate': '2017-03-10', 'lastUpdatePostDateStruct': {'date': '2022-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Treatment toxicities', 'timeFrame': 'every week during NACRT (up to 6 weeks)', 'description': 'CTCAE Version 3.0'}, {'measure': 'Number of patients completing 100% of their planned radiation dose within 1 week of planned completion date', 'timeFrame': 'post-NACRT (an average of 6 weeks)', 'description': 'Obtained from electronic medical records'}, {'measure': 'Number of patients receiving ≥ 80% of their planned chemotherapy dose', 'timeFrame': 'post-NACRT (an average of 6 weeks)', 'description': 'Obtained from electronic medical records'}, {'measure': 'Pathologic complete response rate', 'timeFrame': 'post-surgery (an average of 12 weeks)', 'description': 'Obtained from electronic medical records'}, {'measure': 'Length of hospital stay', 'timeFrame': 'post-surgery (an average of 12 weeks)', 'description': 'Obtained from electronic medical records'}, {'measure': 'Surgical approach', 'timeFrame': 'post-surgery (an average of 12 weeks)', 'description': 'Obtained from electronic medical records'}, {'measure': 'Ostomy', 'timeFrame': 'post-surgery (an average of 12 weeks)', 'description': 'Obtained from electronic medical records'}, {'measure': 'Sphincter preservation', 'timeFrame': 'post-surgery (an average of 12 weeks)', 'description': 'Obtained from electronic medical records'}, {'measure': 'Blood loss', 'timeFrame': 'post-surgery (an average of 12 weeks)', 'description': 'Obtained from electronic medical records'}, {'measure': 'Number of positive lymph nodes', 'timeFrame': 'post-surgery (an average of 12 weeks)', 'description': 'Obtained from electronic medical records'}], 'primaryOutcomes': [{'measure': 'Change in Cardiorespiratory fitness', 'timeFrame': 'pre-NACRT (baseline), post-NACRT (an average of 6 weeks)', 'description': 'VO2 peak'}], 'secondaryOutcomes': [{'measure': 'Cardiorespiratory fitness', 'timeFrame': 'pre-surgery (an average of 12 weeks)', 'description': 'VO2 peak'}, {'measure': 'Functional fitness', 'timeFrame': 'pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)', 'description': "Senior's Fitness Test"}, {'measure': 'Generic quality of life', 'timeFrame': 'pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)', 'description': 'European Organisation for Research and Treatment of Cancer core 30-item questionnaire'}, {'measure': 'Disease specific quality of life', 'timeFrame': 'pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)', 'description': 'European Organisation for Research and Treatment of Cancer questionnaire module for colorectal cancer'}, {'measure': 'Symptom burden', 'timeFrame': 'pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)', 'description': 'M.D. Anderson Symptom Inventory'}, {'measure': 'Exercise motivation', 'timeFrame': 'pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)', 'description': 'Theory of planned behaviour'}, {'measure': 'Eligibility rate', 'timeFrame': 'up to 20 months', 'description': 'Number of eligible patients divided by the number of rectal cancer patients scheduled to receive long-course NACRT'}, {'measure': 'Recruitment rate', 'timeFrame': 'up to 20 months', 'description': 'Number of patients randomized divided by the number of eligible patients'}, {'measure': 'Exercise adherence rate', 'timeFrame': 'post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)', 'description': 'Exercise adherence during NACRT will be assessed by the number of exercise sessions attended out of 18 as well as adherence to the intensity and duration of the HIT intervals. Exercise adherence to the unsupervised exercise after NACRT will be assessed by self-report using the Godin Leisure-Time Exercise.'}, {'measure': 'Follow-up assessment rate', 'timeFrame': 'post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)', 'description': 'Number of patients in each group completing the objective outcomes (cardiorespiratory fitness and functional fitness) and patient-reported outcomes (quality of life, symptom burden) at each timepoint.'}, {'measure': 'Safety: Adverse event rate', 'timeFrame': 'post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)', 'description': 'Number of serious adverse events that occur during exercise testing or the supervised exercise sessions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise', 'Cancer', 'Symptom management', 'Quality of life', 'presurgical', 'chemoradiotherapy', 'Physical Fitness'], 'conditions': ['Rectal Cancer']}, 'referencesModule': {'references': [{'pmid': '34158253', 'type': 'BACKGROUND', 'citation': 'Morielli AR, Usmani N, Boule NG, Severin D, Tankel K, Joseph K, Nijjar T, Fairchild A, Courneya KS. Feasibility, Safety, and Preliminary Efficacy of Exercise During and After Neoadjuvant Rectal Cancer Treatment: A Phase II Randomized Controlled Trial. Clin Colorectal Cancer. 2021 Sep;20(3):216-226. doi: 10.1016/j.clcc.2021.05.004. Epub 2021 May 26.'}, {'pmid': '34841461', 'type': 'BACKGROUND', 'citation': 'Morielli AR, Boule NG, Usmani N, Tankel K, Joseph K, Severin D, Fairchild A, Nijjar T, Courneya KS. Effects of exercise during and after neoadjuvant chemoradiation on symptom burden and quality of life in rectal cancer patients: a phase II randomized controlled trial. J Cancer Surviv. 2023 Aug;17(4):1171-1183. doi: 10.1007/s11764-021-01149-w. Epub 2021 Nov 29.'}, {'pmid': '37061361', 'type': 'DERIVED', 'citation': 'Arthuso FZ, Morielli AR, Usmani N, Joseph K, Nijjar T, Tankel K, Fairchild A, Severin D, Boule NG, Courneya KS. Effects of Exercise on Motivational Outcomes in Rectal Cancer Patients During and After Neoadjuvant Chemoradiation: A Phase II Randomized Controlled Trial. Semin Oncol Nurs. 2023 Aug;39(4):151419. doi: 10.1016/j.soncn.2023.151419. Epub 2023 Apr 13.'}, {'pmid': '29329555', 'type': 'DERIVED', 'citation': 'Morielli AR, Usmani N, Boule NG, Severin D, Tankel K, Nijjar T, Joseph K, Fairchild A, Courneya KS. Exercise during and after neoadjuvant rectal cancer treatment (the EXERT trial): study protocol for a randomized controlled trial. Trials. 2018 Jan 12;19(1):35. doi: 10.1186/s13063-017-2398-1.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to investigate if aerobic exercise during and after neoadjuvant chemoradiotherapy (NACRT) can improve outcomes for rectal cancer patients.', 'detailedDescription': 'The EXERT trial is a single-center, prospective, two-armed, phase II randomized controlled trial designed to test the preliminary efficacy of exercise training in this clinical setting and to further evaluate its feasibility and safety. Participants will be 60 rectal cancer patients scheduled to receive long-course NACRT followed by total mesorectal excision. Participants will be randomly assigned to exercise training or usual care. Participants in the exercise training group will be asked to complete three supervised, high-intensity interval training sessions/week during NACRT and ≥ 150 min/week of unsupervised, moderate-to-vigorous-intensity, continuous exercise training after NACRT prior to surgery. Participants in the usual care group will be asked not to increase their exercise from baseline. Assessments will be completed pre NACRT, post NACRT, and pre surgery. The primary endpoint will be cardiorespiratory fitness (VO2 peak) at the post-NACRT time point assessed by a graded exercise test. Secondary endpoints will include functional fitness, quality of life, and symptom management. Exploratory clinical endpoints will include treatment toxicities, treatment completion, treatment response, and surgical complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients scheduled to receive long-course (5-6 weeks) of NACRT followed by total mesorectal excision\n\nExclusion Criteria:\n\n* Unable to consent\n* Unable to perform aerobic exercise\n* Intention to engage in a structured exercise program during NACRT and/or after NACRT and prior to surgery'}, 'identificationModule': {'nctId': 'NCT03082495', 'acronym': 'EXERT', 'briefTitle': 'Exercise During and After Neoadjuvant Rectal Cancer Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'A Phase II Randomized Controlled Trial of Aerobic Exercise in Rectal Cancer Patients During and After Neoadjuvant Chemoradiotherapy', 'orgStudyIdInfo': {'id': 'HREBA.CC-16-0986'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise', 'description': 'Aerobic exercise', 'interventionNames': ['Behavioral: Exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Standard medical care'}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': 'Supervised high-intensity interval training (HIIT) during NACRT followed by unsupervised moderate-to-vigorous intensity continuous exercise training after the completion of NACRT and before surgery', 'armGroupLabels': ['Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G 1Z2', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Cross Cancer Institute', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'Kerry S Courneya, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Cancer Society (CCS)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}