Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2026-01-01 @ 12:49 AM
Study NCT ID:
NCT00730808
Status:
COMPLETED
Last Update Posted:
2010-05-19
First Post:
2008-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness and Tolerability of an Oral Nutritional Supplement (PreOP Booster) Given Before Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'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': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005502', 'term': 'Food'}], 'ancestors': [{'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-18', 'studyFirstSubmitDate': '2008-08-05', 'studyFirstSubmitQcDate': '2008-08-07', 'lastUpdatePostDateStruct': {'date': '2010-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immunoinflammatory parameters', 'timeFrame': 'on day -2, -1, 1, 2, 3, 5, and 7'}, {'measure': 'Antioxidant / oxidant parameters', 'timeFrame': 'on day -2, 1, 3, 5, and 7'}, {'measure': 'Ischemia / reperfusion injury parameters', 'timeFrame': 'on day -2, 1, 3, 5, and 7'}], 'secondaryOutcomes': [{'measure': 'pre-and postoperative discomfort (well-being)', 'timeFrame': 'on day -1, and 0'}, {'measure': 'hand grip strength', 'timeFrame': 'on day -2, 1, 2, 3, 5, and 7'}, {'measure': 'GI tolerance', 'timeFrame': 'on day -1, 0, 1, 2, and 7'}, {'measure': 'Safety', 'timeFrame': 'on day -1, 0, 1, 2, 3, 5, and 7'}]}, 'conditionsModule': {'keywords': ['Enteral nutritional regimen prior to surgery'], 'conditions': ['Rectal Tumors']}, 'descriptionModule': {'briefSummary': 'The aim of this pilot study is to investigate effectiveness, tolerability and safety of an oral nutritional supplement (PreOP Booster), given to rectal tumour patients prior to low anterior resection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* rectal tumour with indication for elective low anterior resection (open surgery, not laparoscopic surgery) or abdominoperineal resection (APR)\n* preoperative radiotherapy (5x5 Gy) or chemoradiation\n* loop ileostoma or colostoma;\n\nExclusion Criteria:\n\n* severe malnutrition\n* severe renal insufficiency\n* diabetes mellitus I or II\n* concomitant thyroid medication\n* corticosteroids\n* diuretic medication and antihypertensive medication\n* known or suspected allergy to any component of the investigational product(s)'}, 'identificationModule': {'nctId': 'NCT00730808', 'briefTitle': 'Effectiveness and Tolerability of an Oral Nutritional Supplement (PreOP Booster) Given Before Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fresenius Kabi'}, 'officialTitle': 'Efficacy and Tolerability of a Preoperative Oral Nutritional Supplement (PreOP Booster) vs. Placebo in Surgical Patients (Pilot Study)', 'orgStudyIdInfo': {'id': 'N-POB-04-NL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test', 'description': 'Oral nutritional supplement: assignment according to consecutive random numbers.', 'interventionNames': ['Dietary Supplement: PreOP Booster (food for special medical purposes)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Assignment according to consecutive random numbers.', 'interventionNames': ['Dietary Supplement: PreOP Booster (food for special medical purposes)']}], 'interventions': [{'name': 'PreOP Booster (food for special medical purposes)', 'type': 'DIETARY_SUPPLEMENT', 'description': '3x1 dosage is given prior to surgery: 2x1 the day prior to surgery; 1x1 3-4h prior to initiation of anaesthesia;', 'armGroupLabels': ['Control', 'Test']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alkmaar', 'country': 'Netherlands', 'facility': 'Medical Center Alkmaar', 'geoPoint': {'lat': 52.63167, 'lon': 4.74861}}], 'overallOfficials': [{'name': 'Paul A.M. van Leeuwen, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Amsterdam; The Netherlands'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fresenius Kabi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dr. Steffen Benzing', 'oldOrganization': 'Kabi Innovation Centre, Fresenius Kabi Deutschland GmbH'}}}}