Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2026-03-01 @ 6:01 PM
Study NCT ID:
NCT03316157
Status:
COMPLETED
Last Update Posted:
2020-03-11
First Post:
2017-09-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise and Nutritional Rehabilitation in Patients With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002100', 'term': 'Cachexia'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013851', 'term': 'Thinness'}, {'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': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised (1:1) unblinded feasibility trial of a rehabilitation programme (exercise and nutrition) versus waiting list control, in patients with advanced cancer'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-07-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-10', 'studyFirstSubmitDate': '2017-09-22', 'studyFirstSubmitQcDate': '2017-10-18', 'lastUpdatePostDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Rehabilitation programme', 'timeFrame': '8 weeks', 'description': 'Compliance with treatment and trial procedures'}], 'secondaryOutcomes': [{'measure': 'Patient quality of life', 'timeFrame': '8 weeks', 'description': 'Measured by EORTC QLQ-C15-PAL questionnaire'}, {'measure': 'Carer quality of life', 'timeFrame': '8 weeks', 'description': 'Measured by CQOLC questionnaire'}, {'measure': 'Change in physical function', 'timeFrame': '8 weeks', 'description': 'Mean daily step count, measured by Physical Activity Meter over 5 days'}, {'measure': 'Change in physical function', 'timeFrame': '8 weeks', 'description': 'Measured by two-minute walk test (metres/feet covered)'}, {'measure': 'Change in physical function', 'timeFrame': '8 weeks', 'description': 'Measured by Karnofsky performance status (KPS) at baseline, mid and endpoint'}, {'measure': 'Change in physical function', 'timeFrame': '8 weeks', 'description': 'Measured by timed up-and-go test (Seconds)'}, {'measure': 'Change in physical function', 'timeFrame': '8 weeks', 'description': 'Measured by Life Space Assessment scores'}, {'measure': 'Sleep quality', 'timeFrame': '8 weeks', 'description': 'Measured by physical activity meter at baseline and endpoint (Mean sleep hours, mean hours restless and hours awake)'}, {'measure': 'Nutritional status', 'timeFrame': '8 weeks', 'description': 'Height and weight measured at baseline, mid and endpoint assessment (m, Kg and combined as kg/m2)'}, {'measure': 'Nutritional status', 'timeFrame': '8 weeks', 'description': 'Measured by PG-SGA nutritional assessment (PG-SGA point score)'}, {'measure': 'Contamination in the control group', 'timeFrame': '8 weeks', 'description': 'Measured by dietary intake using 24 hour recall (patient diary entries)'}, {'measure': 'Contamination in the control group', 'timeFrame': '8 weeks', 'description': 'Measured by change in measures of physical function (see outcomes 4-8) in control group from baseline measurement to endpoint'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cachexia; Cancer', 'Diet Modification', 'Physical Activity', 'Advanced Cancer']}, 'descriptionModule': {'briefSummary': 'In patients with incurable cancer, general deterioration in their ability to walk, exercise and care for themselves is often regarded as an inevitable consequence of this. In 2015, Hospice UK published a report advocating "Rehabilitative Palliative Care".\n\nHowever there is limited robust evidence on which to base this approach. Reviews of the literature show limited study numbers but do suggest that rehabilitation may be feasible for advanced cancer patients. However key components were not clear and no recommendations could be given.\n\nThis trial is designed primarily to test the feasibility of a rehabilitation programme (exercise and nutritional supplementation) in advanced cancer patients. Feasibility will be the primary outcome measure including rates of recruitment and compliance. Secondary outcome measures include impact on physical function, nutritional status, quality of life for patients and their carers. We will also assess the health economic impact by assessing patient health facility use throughout the trial.\n\n40 patients with advanced cancer living in the community will be recruited from two hospice palliative care teams in Edinburgh. These patients will be randomised in to either the treatment arm: the rehabilitation programme plus standard care, or the control arm: standard care alone. The treatment arm will consist of an 8 week rehabilitation programme, supervised at weekly clinics by a physiotherapist and dietician.\n\nTo minimise contamination the control group will be offered the treatment at the end of the 8 weeks (waiting list control).\n\nMeasurements will be made for both groups and compared at baseline (week 0), midpoint (week 5) and endpoint (week 9). Recommendations for a larger UK wide trial will be made from the findings of this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Diagnosis of advanced cancer (defined as metastatic or locally advanced cancer not amenable to curative treatment).\n2. Outpatient\n3. ≥18years\n4. Karnofsky score ≥ 60\n5. Prognosis greater than 3 months\n6. Able to complete trial based assessments\n7. Under care of community services at Marie Curie or St Columba's Hospices\n8. Ability to comply with trial protocol\n9. Ability to provide and have capacity to consent\n10. Agree to attend trial centre for trial related activity (St Columba's Hospice)\n\nExclusion Criteria:\n\n1. Undergoing anti-cancer therapy (hormonal treatment or bisphosphonates permitted)\n2. Using enteral nutrition (NG or similar) or parenteral nutrition\n3. Co-enrolment in drug trials\n4. Inability to swallow"}, 'identificationModule': {'nctId': 'NCT03316157', 'acronym': 'ENeRgy', 'briefTitle': 'Exercise and Nutritional Rehabilitation in Patients With Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Edinburgh'}, 'officialTitle': 'Exercise and Nutritional Rehabilitation in Patients With Cancer, Randomised (1:1) Unblinded Feasibility Trial of a Rehabilitation Programme (Exercise and Nutrition) Versus Waiting List Control, in Patients With Advanced Cancer', 'orgStudyIdInfo': {'id': 'AC17085'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rehabilitation', 'description': 'Advanced cancer patients will receive an 8 week rehabilitation intervention consisting of physical exercise and nutritional supplementation, along with standard care', 'interventionNames': ['Dietary Supplement: ProSure', 'Behavioral: Physical Exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Waiting list Control', 'description': 'Standard care alone for the 8 week trial period, followed by participants being offered the rehabilitation programme'}], 'interventions': [{'name': 'ProSure', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patients will take 2x 220mL nutritional supplements per day for 8 weeks and be given dietary advice to optimise their nutrition', 'armGroupLabels': ['Rehabilitation']}, {'name': 'Physical Exercise', 'type': 'BEHAVIORAL', 'description': 'Patients will receive an individualised exercise regimen consisting of 60 minutes aerobic and 3x resistance elements per week', 'armGroupLabels': ['Rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EH4 2XR', 'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'University of Edinburgh', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Edinburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'Marie Curie Hospice, Belfast', 'class': 'OTHER'}, {'name': 'Accord Clinical Research', 'class': 'OTHER'}, {'name': 'NHS Lothian', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}