Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 4:33 PM
Study NCT ID:
NCT05495360
Status:
COMPLETED
Last Update Posted:
2025-02-19
First Post:
2022-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Omega 3 Enriched Oral Nutritional Supplement on Nutritional Status of CRC and NSCLC Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019587', 'term': 'Dietary Supplements'}], 'ancestors': [{'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-09-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-14', 'studyFirstSubmitDate': '2022-08-02', 'studyFirstSubmitQcDate': '2022-08-08', 'lastUpdatePostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in EPA concentration in the phospholipid fraction of the erythrocyte membrane [% of total fatty acids]', 'timeFrame': 'at end of first in-study treatment cycle compared to baseline'}], 'secondaryOutcomes': [{'measure': 'Change in protein intake [g/day] [key secondary outcome)', 'timeFrame': 'at end of first in-study treatment cycle compared to baseline'}, {'measure': 'Change in protein intake [g/kg bw/day] [key secondary outcome)', 'timeFrame': 'at end of first in-study treatment cycle compared to baseline'}, {'measure': 'Change in energy intake [kcal/day]', 'timeFrame': 'at end of first in-study treatment cycle compared to baseline'}, {'measure': 'Change in energy intake [kcal/kg bw/day]', 'timeFrame': 'at end of first in-study treatment cycle compared to baseline'}, {'measure': 'Provided vitamin D supplementation [µg/day] by the test product', 'timeFrame': 'Throughout total intervention period - about 2 months'}, {'measure': 'Change in fatty acid profile in the phospholipid fraction of the cell membrane of erythrocytes [% of total fatty acids]', 'timeFrame': 'at end of first in-study treatment cycle compared to baseline'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oral nutritional supplement', 'Oncology', 'Omega 3'], 'conditions': ['Malnutrition', 'Oncology']}, 'descriptionModule': {'briefSummary': 'A single arm intervention study examining the effect of an omega 3 enriched oral nutritional supplement on nutritional status of CRC and NSCLC patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Histologically proven CRC or histologically or cytologically proven NSCLC\n2. Eligible and scheduled for at least 2 cycles of 4-week cycles of systemic treatment, 3 cycles of 3-week cycles of systemic treatment or 4 cycles of 2-week cycles of systemic treatment\n3. At risk of malnutrition or malnourished \\[PG-SGA-SF \\> 4\\]\n4. Performance status ECOG 0 or 1\n5. Weight loss grade 0-3 according to Martin et al1\n6. \\<11% weight loss in the past 6 months\n7. Age ≥ 18 years\n8. Written informed consent\n\nExclusion Criteria:\n\n1. Presence of ileostoma or ileal pouch\n2. GI-related or major surgery in 30 days prior to baseline\n3. Severe hypercalcemia, i.e. total calcium level, corrected for albumin ≥ 14.0 mg/dL (3.5 mmol/L)\n4. Use of ONS, enteral nutrition or parenteral nutrition within 14 days prior to entry into the study\n5. Use of fish oil containing supplements, within 30 days prior to entry into the study or expected to use this during the study\n6. Use of more than 200 iU/day of vitamin D containing supplements within 30 days prior to entry into the study or expected to use this during the study\n7. Life expectancy of \\< 3 months\n8. Severe renal dysfunction (\\<29 ml/min/1.73m2 eGRF or albumin:creatinine (ACR) \\> 30) or hepatic encephalopathy\n9. Allergy to cow's milk protein or fish, known protein sensitivity or suffering galactosemia\n10. Known pregnancy or lactation\n11. Current alcohol or drug abuse in opinion of the investigator\n12. Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements\n13. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study"}, 'identificationModule': {'nctId': 'NCT05495360', 'acronym': 'OMENS', 'briefTitle': 'Effect of Omega 3 Enriched Oral Nutritional Supplement on Nutritional Status of CRC and NSCLC Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nutricia Research'}, 'officialTitle': 'Effect of Omega 3 Enriched Oral Nutritional Supplement on Nutritional Status of CRC and NSCLC Patients', 'orgStudyIdInfo': {'id': 'SBB20R&35115'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'twice daily serving of the study product', 'interventionNames': ['Dietary Supplement: Oral Nutritional Supplement']}], 'interventions': [{'name': 'Oral Nutritional Supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'twice daily serving of the study product', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brussels', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Roeselare', 'country': 'Belgium', 'facility': 'AZ Delta', 'geoPoint': {'lat': 50.94653, 'lon': 3.12269}}, {'city': 'Brno', 'country': 'Czechia', 'facility': 'Faculty Hospital Brno', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Fakultní nemocnice Bulovka', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Cork', 'country': 'Ireland', 'facility': 'Cork University Hospital', 'geoPoint': {'lat': 51.89797, 'lon': -8.47061}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nutricia Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}