Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2026-01-04 @ 9:25 PM
Study NCT ID:
NCT00919659
Status:
COMPLETED
Last Update Posted:
2009-06-12
First Post:
2009-06-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Parenteral Nutrition Support for Patients With Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D006963', 'term': 'Hyperphagia'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010288', 'term': 'Parenteral Nutrition'}], 'ancestors': [{'id': 'D005248', 'term': 'Feeding Methods'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D018529', 'term': 'Nutritional Support'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2004-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-11', 'studyFirstSubmitDate': '2009-06-09', 'studyFirstSubmitQcDate': '2009-06-11', 'lastUpdatePostDateStruct': {'date': '2009-06-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'nutritional status presented by phase angle', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'quantity of port infections, quantity of oedema, quantity of diarrhea', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['parenteral nutrition', 'cancer cachexia', 'pancreatic cancer'], 'conditions': ['Cancer Cachexia', 'Pancreatic Cancer']}, 'referencesModule': {'references': [{'pmid': '20214798', 'type': 'DERIVED', 'citation': 'Pelzer U, Arnold D, Govercin M, Stieler J, Doerken B, Riess H, Oettle H. Parenteral nutrition support for patients with pancreatic cancer. Results of a phase II study. BMC Cancer. 2010 Mar 9;10:86. doi: 10.1186/1471-2407-10-86.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the additional nutrition support is improving the nutritional status of patients suffering cancer caxechia or not.', 'detailedDescription': 'To examine the impact of additional parenteral nutrition (APN) we prospective evaluated 32 pts suffering APC and progressive cachexia. This assay is based on a bioelectrical impedance analysis (BIA) as a proven tool for nutritional investigation in patients with chronic disease. Phase angle, determined by BIA, has been found to be a prognostic indicator in several chronic and malignant conditions, such as HIV, liver cirrhosis, chronic obstructive pulmonary disease lung cancer and pancreatic cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histological proved pancreatic cancer\n* progressive cancer cachexia\n* refractive to enteral supplementation\n* informed consent\n\nExclusion Criteria:\n\n* prefinal status\n* septic disease'}, 'identificationModule': {'nctId': 'NCT00919659', 'briefTitle': 'Parenteral Nutrition Support for Patients With Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'CONKO-Studiengruppe'}, 'officialTitle': 'Parenteral Nutrition Support for Patients With Pancreatic Cancer. A Phase II Study.', 'orgStudyIdInfo': {'id': 'C25.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'parenteral nutrition', 'description': '25kcal/kg/bw /day via parenteral support', 'interventionNames': ['Dietary Supplement: parenteral nutrition']}], 'interventions': [{'name': 'parenteral nutrition', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['no specific brand name'], 'description': '25kcal/kg bw with parenteral nutrition', 'armGroupLabels': ['parenteral nutrition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13353', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Universitätsmedizin Berlin - Charité', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'helmut oettle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CONKO-Studiengruppe'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CONKO-Studiengruppe', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fresenius AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Helmut Oettle MD', 'oldOrganization': 'Universitätsmedizin Berlin - Charité'}}}}