Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-28 @ 4:06 AM
Study NCT ID:
NCT05677958
Status:
COMPLETED
Last Update Posted:
2023-01-10
First Post:
2022-11-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protein Intake in Patients With Colorectal or Lung Cancer When Receiving a Nutritional Supplement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'randomised controlled, open label, parallel-group, multi-centre and multicountry study'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Test group: receiving daily 2 servings of a low volume, energy dense and high protein oral nutritional supplement (ONS) Control group: not receiving any study product. These subjects will be receiving standard of care.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-09', 'studyFirstSubmitDate': '2022-11-23', 'studyFirstSubmitQcDate': '2023-01-09', 'lastUpdatePostDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The average protein intake (g/day and g/kg/day) corrected for baseline at the end of the first treatment cycle assessed with a 3-day food diary.', 'timeFrame': 'end of first treatment cycle (cycle length varies from 2-week, 3-week, 4-week or 6-weeks)', 'description': 'The average protein intake (g/day and g/kg/day) corrected for baseline at the end of the first treatment cycle assessed with a 3-day food diary.'}], 'secondaryOutcomes': [{'measure': 'Proportion of subjects with a protein intake above the lower limit of the ESPEN recommendations for protein intake', 'timeFrame': 'end of first treatment cycle (cycle length varies from 2-week, 3-week, 4-week or 6-weeks)', 'description': 'Proportion of subjects with a protein intake above the lower limit of the ESPEN recommendations for protein intake'}, {'measure': 'Change of body weight.', 'timeFrame': 'during 12 weeks (baseline till end of intervention at week 12]', 'description': 'change of body weight measured with weighting scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer', 'Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The PROTEOS study is an randomized controlled, open label, parallel-group, multi-centre and multicounty interventional study to assess the acceptance and implementation of Compact Protein, a low volume, energy dense and high protein oral nutritional support in clinical practice according to the ESPEN guidelines in colorectal and lung cancer patients undergoing chemo(radio)- or immunotherapy treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically proven CRC stage IIB, III or IV or histologically or cytologically proven NSCLC stage III or IV\n* Eligible and scheduled for first line chemotherapy, concurrent chemoradiotherapy or immunotherapy treatment with a planned duration of at least 12 weeks\n* Performance status Eastern Cooperative Oncology Group (ECOG) score 0 or 1\n* Age ≥ 18 years\n* Written informed consent\n\nExclusion Criteria:\n\n* Scheduled for first line chemotherapy, concurrent chemoradiotherapy or immunotherapy treatment starting ≤4 days after randomization\n* Received radiotherapy within 2 months prior to the study\n* Weight loss \\>10% in the last 6 months\n* Body Mass Index \\< 20.0 kg/m2\n* Life expectancy \\< 3 months\n* Prescription of oral nutritional supplementation (ONS) before start of first line treatment based on hospital's standard practice\n* Presence of ileostoma or ileal pouch\n* Contra-indications to oral feeding, high protein nutrition or to the test product (including galactosaemia) in the opinion of the investigator\n* Known pregnancy or lactation\n* Current alcohol or drug abuse in the opinion of the investigator\n* Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements\n* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study"}, 'identificationModule': {'nctId': 'NCT05677958', 'acronym': 'PROTEOS', 'briefTitle': 'Protein Intake in Patients With Colorectal or Lung Cancer When Receiving a Nutritional Supplement', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nutricia Research'}, 'officialTitle': 'Protein Intake in Patients With Colorectal or Lung Cancer During First Line Treatment With Chemo (Radio) - or Immunotherapy When Receiving a Low Volume, Energy Dense and High Protein Oral Nutritional Supplement: a Randomized, Controlled Study', 'orgStudyIdInfo': {'id': 'MPR16TA06151'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Test group', 'description': '125 mL Fortimel/Nutridrink Compact Protein', 'interventionNames': ['Dietary Supplement: 125 mL Fortimel/Nutridrink Compact Protein']}, {'type': 'NO_INTERVENTION', 'label': 'Control group'}], 'interventions': [{'name': '125 mL Fortimel/Nutridrink Compact Protein', 'type': 'DIETARY_SUPPLEMENT', 'description': '125 mL Fortimel/Nutridrink Compact Protein®\\* two servings per day (300 kcal, 18 g protein per serving).', 'armGroupLabels': ['Test group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ghent', 'country': 'Belgium', 'facility': 'UZ Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Sint-Niklaas', 'country': 'Belgium', 'facility': 'AZ Nikolaas', 'geoPoint': {'lat': 51.16509, 'lon': 4.1437}}, {'city': 'Tallinn', 'country': 'Estonia', 'facility': 'North Estonia Medical Centre', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'city': 'Tartu', 'country': 'Estonia', 'facility': 'Tartu University Hospital', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}, {'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'National Cancer Institute', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'city': 'Breda', 'country': 'Netherlands', 'facility': 'Amphia Ziekenhuis', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Maastricht University Medical Center', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'city': 'Nieuwegein', 'country': 'Netherlands', 'facility': 'St. Antonius Hospital', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}, {'city': 'Veldhoven', 'country': 'Netherlands', 'facility': 'Máxima Medisch Centrum', 'geoPoint': {'lat': 51.41833, 'lon': 5.40278}}, {'city': 'Zaandam', 'country': 'Netherlands', 'facility': 'Zaans Medisch Centrum', 'geoPoint': {'lat': 52.43854, 'lon': 4.82643}}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Poznan', 'country': 'Poland', 'facility': 'Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Szczecin', 'country': 'Poland', 'facility': 'Hospital of Szczecin', 'geoPoint': {'lat': 53.42894, 'lon': 14.55302}}, {'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Centro Hospitalar Universitario Lisboa Norte EPE', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nutricia Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}