Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2026-01-02 @ 5:39 PM
Study NCT ID:
NCT03123432
Status:
COMPLETED
Last Update Posted:
2017-04-21
First Post:
2017-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunomodulating Nutrients in Perioperative Patients With Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'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': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-20', 'studyFirstSubmitDate': '2017-04-05', 'studyFirstSubmitQcDate': '2017-04-20', 'lastUpdatePostDateStruct': {'date': '2017-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'immunomodulating effects', 'timeFrame': 'at discharge from the hospital or 14 days after surgery, whichever occurred first', 'description': 'Inflammatory markers including interleukin (IL)-6, C-reactive protein (CRP), and tumor necrosis factor-α (TNF-α) were employed to assess inflammatory processes.'}], 'secondaryOutcomes': [{'measure': 'blood glucose', 'timeFrame': 'at discharge from the hospital or 14 days after surgery, whichever occurred first'}, {'measure': 'blood urine nitrogen', 'timeFrame': 'at discharge from the hospital or 14 days after surgery, whichever occurred first'}, {'measure': 'blood aspartate aminotransferase (AST) in U/L', 'timeFrame': 'at discharge from the hospital or 14 days after surgery, whichever occurred first'}, {'measure': 'blood alanine aminotransferase (ALT) in U/L', 'timeFrame': 'at discharge from the hospital or 14 days after surgery, whichever occurred first'}, {'measure': 'blood triglycerides (TG) in mg/dL', 'timeFrame': 'at discharge from the hospital or 14 days after surgery, whichever occurred first'}, {'measure': 'blood cholesterol in mg/mL', 'timeFrame': 'at discharge from the hospital or 14 days after surgery, whichever occurred first'}, {'measure': 'blood low-density lipoprotein (LDL) in mg/mL', 'timeFrame': 'at discharge from the hospital or 14 days after surgery, whichever occurred first'}, {'measure': 'blood high-density lipoprotein (HDL) in mg/mL', 'timeFrame': 'at discharge from the hospital or 14 days after surgery, whichever occurred first'}, {'measure': 'blood sodium (Na) mEq/L', 'timeFrame': 'at discharge from the hospital or 14 days after surgery, whichever occurred first'}, {'measure': 'blood leukocyte count cells/μL', 'timeFrame': 'at discharge from the hospital or 14 days after surgery, whichever occurred first'}, {'measure': 'blood albumin in g/dL', 'timeFrame': 'at discharge from the hospital or 14 days after surgery, whichever occurred first'}, {'measure': 'blood prealbumin in mg/dL', 'timeFrame': 'at discharge from the hospital or 14 days after surgery, whichever occurred first'}, {'measure': 'body mass index (BMI) in kg/m^2', 'timeFrame': 'at discharge from the hospital or 14 days after surgery, whichever occurred first'}, {'measure': 'postoperative complications', 'timeFrame': 'at discharge from the hospital or 14 days after surgery, whichever occurred first', 'description': 'postoperative complications that related to surgery'}, {'measure': 'time to first bowel action', 'timeFrame': 'at discharge from the hospital or 14 days after surgery, whichever occurred first', 'description': 'interval of surgery to first bowel action (hours)'}, {'measure': 'length of hospital stay after surgery', 'timeFrame': 'at discharge from the hospital or 14 days after surgery, whichever occurred first', 'description': 'length of hospital stay after surgery (days)'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['immunomodulating nutrients'], 'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'The survey is a phase IV, prospective randomized clinical trial to determine whether an immunomodulating nutrient-enriched diet compared to a standard diet can improve nutritional status and reduce postoperative infection and surgery-induced immune suppression in patients with gastric cancer or GIST undergoing major surgery in a single medical center.', 'detailedDescription': 'Primary Objective:\n\n1. The primary end points:\n\n To evaluate the effect of immunomodulating diets on the postoperative inflammatory response: including interleukin (IL)-6, C-reactive protein (CRP), and tumor necrosis factor-α (TNF-α).\n2. Secondary Objectives:\n\n(1). Biochemistry parameters: glucose,blood urine nitrogen, creatinine, aspartate aminotransferase, alanine aminotransferase, triglycerides, cholesterol, low-density lipoprotein, high-density lipoprotein, sodium, and leukocyte count.\n\n(2). Nutritional status: albumin, prealbumin, BMI (3). Adverse events (4). Clinical outcomes: postoperative complications, time to first bowel action and length of hospital stay after surgery.\n\nNumber of Subjects: Eligible patients will be randomized in 2 arms in the ratio of 1:1, to reach 15 patients at least in each.\n\nPlan of the Study:\n\n1. This is a randomized, comparative, double blinded study in 2 arms.\n2. Study Schedule Study date: the time getting approval letter issued by both regulatory authority and institutional review board (IRB). Duration of the study: 5 years.\n3. Duration of Treatment: Treatment was administered before curative surgery for gastric adenocarcinoma or gastric GIST, and postoperative day 5-14 or to discharge whichever occurred first, or consent withdrawal during any time of the study, when the patient would be withdrawn.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 20-85 years old\n* Histologically proven primary gastric cancer or GIST.\n* Patients was planning to receive elective curative gastric surgery, such as partial gastrectomy, subtotal gastrectomy, proximal gastrectomy, total gastrectomy, etc.\n* Patient is able to understand the requirements of the study and written informed consent was obtained from each subject.\n\nExclusion Criteria:\n\n* They were less than 20 years or over 85 years old\n* Hepatic dysfunction or bile stasis (serum total bilirubin \\>2.5 mg/dL)\n* Renal dysfunction (serum creatinine \\>1.5 mg/dL), or required hemodialysis\n* Cardiac dysfunction (NYHA functional class \\>III, or stroke history)\n* Severe hypoalbuminemia (albumin \\<2.5 g/dL)\n* Karnofsky performance status less than 60\n* Overweight (body mass index \\[BMI\\] \\>30 kg/m2)\n* Exhibited drug abuse or chronic alcoholism\n* Had life-threatening disease, or underwent emergent surgery\n* With infection or bowel obstruction\n* Pregnant or lactating\n* Had received chemotherapy within 14 days of the initiation of the trial\n* Had received immunosuppressive therapy or had immunological diseases recently\n* Had already participated in another clinical study with an investigational drug or an investigational medical device within a month of the initiation or during the study\n* Hypersensitive to casein, fish oil, soybean, or corn oil'}, 'identificationModule': {'nctId': 'NCT03123432', 'briefTitle': 'Immunomodulating Nutrients in Perioperative Patients With Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}, 'officialTitle': 'Combination of Arginine, Glutamine, and Omega-3 Fatty Acid Supplements for Perioperative Enteral Nutrition in Surgical Patients With Gastric Adenocarcinoma or Gastrointestinal Stromal Tumor (GIST)', 'orgStudyIdInfo': {'id': 'KMUHIRB-2011-05-01(II)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'immunomodulating nutrients enriched diet', 'description': 'Patients received oral feeding with an ordinary diet plus 400 mL/day (400 kcal/day) of the immunomodulating nutrients enriched diet for 3-5 days before curative surgery for gastric adenocarcinoma or gastric GIST. On postoperative day 3, enteral nutrition (EN) was initiated with 5% glucose in water at a rate of 20 mL/h. On postoperative day 4, patients received a semi-liquid diet plus 400 mL/day (400 kcal/day) of the immunomodulating nutrients enriched diet. From postoperative day 5-14 or to discharge whichever occurred first, 1200 mL/day (1200 kcal/day) of the interventional diet was administered, and an oral soft diet was also administered if no postoperative complications developed and if oral feeding was not prohibited.', 'interventionNames': ['Dietary Supplement: immunomodulating nutrients enriched diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standard diet', 'description': 'Patients received oral feeding with an ordinary diet plus 400 mL/day (400 kcal/day) of the standard diet for 3-5 days before curative surgery for gastric adenocarcinoma or gastric GIST. On postoperative day 3, EN was initiated with 5% glucose in water at a rate of 20 mL/h. On postoperative day 4, patients received a semi-liquid diet plus 400 mL/day (400 kcal/day) of the interventional diet. From postoperative day 5-14 or to discharge whichever occurred first, 1200 mL/day (1200 kcal/day) of the standard diet was administered, and an oral soft diet was also administered if no postoperative complications developed and if oral feeding was not prohibited.', 'interventionNames': ['Dietary Supplement: standard diet']}], 'interventions': [{'name': 'immunomodulating nutrients enriched diet', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['neo-mune'], 'armGroupLabels': ['immunomodulating nutrients enriched diet']}, {'name': 'standard diet', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['standard diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '807', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Chung-Ho Memorial Hospital, Kaohsiung Medical University:', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'overallOfficials': [{'name': 'Jaw-Yuan Wang, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Vice Superintendent', 'investigatorFullName': 'Jaw-Yuan Wang, MD, PhD', 'investigatorAffiliation': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}}}}