Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 5:54 PM
Study NCT ID:
NCT04699760
Status:
COMPLETED
Last Update Posted:
2021-01-07
First Post:
2020-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of n-3 LCPUFAs in Patients With Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005395', 'term': 'Fish Oils'}], 'ancestors': [{'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-06', 'studyFirstSubmitDate': '2020-12-23', 'studyFirstSubmitQcDate': '2021-01-06', 'lastUpdatePostDateStruct': {'date': '2021-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight loss', 'timeFrame': '8 weeks', 'description': 'Difference in weight (kg) from inclusion to 8 week status'}], 'secondaryOutcomes': [{'measure': 'quality of Life score', 'timeFrame': '8 weeks', 'description': 'score - difference from inclusion to 8 week status (EORTC QLQ-C30 questionnaire)'}, {'measure': 'Performance status - common daily abilities', 'timeFrame': '8 weeks', 'description': 'combined scale - score - ADL'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cancer', 'nutrition', 'fish oil'], 'conditions': ['Cancer Cachexia', 'Side Effects', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the effects of n-3 PUFAs on weight, physical funktion and quality of life in patients with colorectal cancer.', 'detailedDescription': 'Primary outcomes:\n\n* Weight\n* Physical function\n* Hand-grip strength\n\nSecondary outcomes:\n\n* Quality of life\n* Mid-upperarm circumference\n* Incorporation of n-3 PUFAs into cell membranes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years\n* Patients with diagnosed colorectal cancer with metastases treated with chemotherapy on Rigshospitalet, Copenhagen\n\nExclusion Criteria:\n\n* \\< 18 years\n* Patients in palliative care\n* patients with haemophilia\n* Patiens in treatment of anti-coagulation\n* Patients with genetic hyperkolesterolemia\n* Pre-dialytic patients (GFR\\<15ml/min/1,73m2 eller kreatinin ≥500 mmol/L)'}, 'identificationModule': {'nctId': 'NCT04699760', 'briefTitle': 'The Effects of n-3 LCPUFAs in Patients With Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Single-blinded, Randomized, Controlled Trial About the Effects of n-3 LCPUFAs on Weight and Functional Status in Patients With Colorectal Cancer.', 'orgStudyIdInfo': {'id': 'H-4-2014-131'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Nutritional supplement without fish oil', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fish oil', 'description': 'Nutritional supplement with fish oil', 'interventionNames': ['Dietary Supplement: Fish Oil']}], 'interventions': [{'name': 'Fish Oil', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Smart Fish - cancer cachexia'], 'description': '8 weeks, 2.2 G EPA/day', 'armGroupLabels': ['Fish oil']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100 OE', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Departmen of Oncology, Rigshospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Jens R Andersen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jens Rikardt Andersen', 'investigatorAffiliation': 'University of Copenhagen'}}}}