Ignite Creation Date:
2025-12-24 @ 5:22 PM
Ignite Modification Date:
2026-01-04 @ 4:40 AM
Study NCT ID:
NCT02828150
Status:
COMPLETED
Last Update Posted:
2025-05-01
First Post:
2016-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integrative Parenteral Nutrition in Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006963', 'term': 'Hyperphagia'}], 'ancestors': [{'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 131}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2016-06-30', 'studyFirstSubmitQcDate': '2016-07-06', 'lastUpdatePostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase angle', 'timeFrame': '7 days', 'description': 'Change in phase angle (a specific body composition parameter assessed by bioelectrical impedance vector analysis) after 7 days of nutritional support'}], 'secondaryOutcomes': [{'measure': 'body weight', 'timeFrame': '7 days', 'description': 'Change in body weight after 7 days of nutritional support'}, {'measure': 'body mass index', 'timeFrame': '7 days', 'description': 'Change in body mass index after 7 days of nutritional support'}, {'measure': 'Handgrip strength', 'timeFrame': '7 days', 'description': 'Changes in muscle strength after 7 days of nutritional support'}, {'measure': 'Number of participants with treatment-related adverse events as assessed by biochemistry', 'timeFrame': '7 days', 'description': 'Changes in biochemistry after 7 days of nutritional support'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Neoplasms', 'Parenteral Nutrition']}, 'referencesModule': {'references': [{'pmid': '25768953', 'type': 'BACKGROUND', 'citation': 'Caccialanza R, Cereda E, Klersy C, Bonardi C, Cappello S, Quarleri L, Turri A, Montagna E, Iacona I, Valentino F, Pedrazzoli P. Phase angle and handgrip strength are sensitive early markers of energy intake in hypophagic, non-surgical patients at nutritional risk, with contraindications to enteral nutrition. Nutrients. 2015 Mar 11;7(3):1828-40. doi: 10.3390/nu7031828.'}]}, 'descriptionModule': {'briefSummary': 'Although it is demonstrated that nutritional support can improve clinical outcomes, the literature shows that approximately 50% of cancer patients are not able to meet their estimated energy requirements. Recent clinical studies suggest that a supplementary support for parenteral nutrition (PN) could significantly help to improve the nutritional status of malnourished cancer patients.\n\nInternational guidelines recommend the use of PN in malnourished, hypophagic, non-surgical cancer patients if enteral nutrition is not feasible and in patients affected by severe iatrogenic gastrointestinal complications and in whom inadequate food intake is anticipated for more than 7 days. However, there are no studies on the effects of integrative PN in hospitalized, malnourished, hypophagic, non-surgical cancer patients.\n\nRecent studies have reported on the validity of bioelectrical impedance vector analysis in monitoring the body composition of patients receiving nutritional support. Particularly, phase angle proved to be a superior prognostic marker than other nutritional screening tools.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of cancer (head-neck, lung, gastrointestinal, pancreas, biliary tract, haematology).\n* Nutritional Risk Screening 2002 score ≥3.\n* Expected duration of parenteral nutrition ≥7 days\n* Availability to planned measurements\n* Contraindication to enteral nutrition support\n* Written informed consent\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Ongoing artificial nutrition before hospitalization\n* Eastern Cooperative Oncology Group performance status \\>2'}, 'identificationModule': {'nctId': 'NCT02828150', 'briefTitle': 'Integrative Parenteral Nutrition in Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}, 'officialTitle': 'Integrative Parenteral Nutrition in Hospitalized, Malnourished, Hypophagic Cancer Patients With Contraindication to Enteral Nutrition', 'orgStudyIdInfo': {'id': '2015013559'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Parenteral nutrition', 'description': 'Patients will receive a tailored nutritional support (parenteral nutrition) to cover estimated protein-calorie requirements', 'interventionNames': ['Dietary Supplement: Parenteral nutrition']}], 'interventions': [{'name': 'Parenteral nutrition', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patients will receive a tailored nutritional support (parenteral nutrition) to cover estimated protein-calorie requirements. Energy: resting energy expenditure \\[Harris-Benedict\\] multiplied by a factor of 1.5. Protein: 1.5 g/kg/day. In obese patients (BMI \\>30 kg/m2) support will be calculated on ideal body weight (BMI=23 kg/m2)', 'armGroupLabels': ['Parenteral nutrition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'country': 'Italy', 'facility': 'Fondazione IRCCS Policlinico San Matteo', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}], 'overallOfficials': [{'name': 'Riccardo Caccialanza, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione IRCCS Policlinico San Matteo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione IRCCS Policlinico San Matteo di Pavia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Riccardo Caccialanza', 'investigatorAffiliation': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}}}}