Ignite Creation Date:
2025-12-24 @ 5:51 PM
Ignite Modification Date:
2026-04-18 @ 8:18 AM
Study NCT ID:
NCT02779868
Status:
COMPLETED
Last Update Posted:
2017-07-25
First Post:
2016-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Omega-3 Supplementation in Cervix Cancer Patients Undergoing Chemoradiotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004281', 'term': 'Docosahexaenoic Acids'}, {'id': 'D000069463', 'term': 'Olive Oil'}], 'ancestors': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-24', 'studyFirstSubmitDate': '2016-05-17', 'studyFirstSubmitQcDate': '2016-05-20', 'lastUpdatePostDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Body composition', 'timeFrame': '45 days', 'description': 'Change from baseline body composition assessed by computed tomography scans before and at the end of chemotherapy treatment (45 day after the first chemotherapy)'}], 'secondaryOutcomes': [{'measure': 'Change in Quality of life', 'timeFrame': '45 days', 'description': 'Change in quality of life assessed by EORCT QL30 questionaire before and at the end of chemotherapy treatment (45 day after the first chemotherapy)'}, {'measure': 'Change in Quality of life', 'timeFrame': '45 days', 'description': 'Change in quality of life assessed by and EQ-5D-3L questionaire before and at the end of chemotherapy treatment (45 day after the first chemotherapy)'}, {'measure': 'Change in IL-6 serum levels', 'timeFrame': '45 days', 'description': 'Change in serum levels of IL-6 (ng/mL) before and at the end of chemotherapy (45 days)'}, {'measure': 'Change in IL-1 serum levels', 'timeFrame': '45 days', 'description': 'Change in serum levels of IL-1 (ng/mL) before and at the end of chemotherapy (45 days)'}, {'measure': 'Change in TNF-alfa serum levels', 'timeFrame': '45 days', 'description': 'Change in serum levels of TNF-alfa (ng/mL) before and at the end of chemotherapy (45 days)'}, {'measure': 'Change in INF-gama serum levels', 'timeFrame': '45 days', 'description': 'Change in serum levels of INF-gama (ng/mL) before and at the end of chemotherapy (45 days)'}, {'measure': 'Change in membrane incorporation of non-esterified fatty acids', 'timeFrame': '45 days', 'description': 'Change in membrane incorporation of non-esterified fatty acids assessed by Gas chromatography of fatty acid methyl esters (nmol/mL)'}, {'measure': 'Change in handgrip strength', 'timeFrame': '45 days', 'description': 'change in handgrip strength before and at the end of chemotherapy treatment (45 days)'}, {'measure': 'Change in functional capacity (30 second stand chair test)', 'timeFrame': '45 days', 'description': 'change in functional capacity assessed by 30 second stand chair test before and at the end of chemotherapy treatment (45 days)'}, {'measure': 'chemoradiotherapy toxicity', 'timeFrame': '15 and 45 days', 'description': 'chemoradiotherapy will be assessed by Chemotherapy toxicity criteria (CTC) version 4.0'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['body composition', 'functional capacity', 'quality of life'], 'conditions': ['Sarcopenia']}, 'descriptionModule': {'briefSummary': 'Cancer cachexia is a complex metabolic process affecting up to 80% of patients suffering from an advanced-stage cancer. Moreover, 20 to 40% of all cancer deaths are caused directly by cachexia. Recently, omega-3 fatty acids have gained interest for their beneficial effects in cancer cachexia. Moreover, nutritional supplementation enriched with omega-3 could potentially maintain body weight in cancer patients undergoing intensive treatment.\n\nThe investigators aims in this study is to evaluate the effect of omega-3 supplementation on body composition, functional capacity, inflammatory profile and quality of life in cervix cancer patients undergoing chemoradiotherapy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cervix cancer at FIGO stage II and III\n* Chemoradiotherapy treatment proposal (cisplatin + radiotherapy)\n* Nutritional diagnosis of pre-cachexia ou cachexia\n\nExclusion Criteria:\n\n* metastasis (FIGO stage IV)\n* Nutritional diagnosis of refractary cachexia'}, 'identificationModule': {'nctId': 'NCT02779868', 'briefTitle': 'Omega-3 Supplementation in Cervix Cancer Patients Undergoing Chemoradiotherapy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Brazilian National Cancer Institute'}, 'officialTitle': 'Effect of Omega-3 Supplementation on Body Composition, Functional Capacity, Inflammatory Profile and Quality of Life in Cervix Cancer Patients Undergoing Chemoradiotherapy', 'orgStudyIdInfo': {'id': '1.150.108/2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Omega-3', 'description': 'Group who will receive 2g eicosapentaenoic (4 capsules) acid per day during the chemoradiotherapy protocol.', 'interventionNames': ['Dietary Supplement: Omega-3']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Olive oil', 'description': 'Group who will receive olive oil per day (4 capsules) during the chemoradiotherapy protocol.', 'interventionNames': ['Dietary Supplement: Olive oil']}], 'interventions': [{'name': 'Omega-3', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['intervention group'], 'description': 'patients included in this group will take 2g (4 capsules) per day of eicosapentaenoic acid.', 'armGroupLabels': ['Omega-3']}, {'name': 'Olive oil', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['placebo group'], 'description': 'patients included in this group will take 4 capsules per day of olive oil.', 'armGroupLabels': ['Olive oil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20220-410', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Brazilian National Cancer Institute', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}], 'overallOfficials': [{'name': 'Mariah A Aredes, Ms', 'role': 'STUDY_CHAIR', 'affiliation': 'Brazilian National Cancer Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brazilian National Cancer Institute', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, Researcher at Brazilian National Cancer Institute', 'investigatorFullName': 'Gabriela Villaça Chaves', 'investigatorAffiliation': 'Brazilian National Cancer Institute'}}}}