Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-02-22 @ 9:38 AM
Study NCT ID:
NCT06059560
Status:
RECRUITING
Last Update Posted:
2023-09-28
First Post:
2023-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutritional Intervention for Patients With Multiple Cancer Types
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D044623', 'term': 'Nutrition Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-22', 'studyFirstSubmitDate': '2023-09-22', 'studyFirstSubmitQcDate': '2023-09-22', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival index', 'timeFrame': '3 years', 'description': 'DFS/OS'}], 'secondaryOutcomes': [{'measure': 'Quality of life index', 'timeFrame': '3years', 'description': 'Perioperative survival index of patients with multiple cancer types'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nutrition', 'prognosis'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'To evaluate the nutritional status of patients with different types of tumors by continuous nutritional intervention and follow-up intervention in the perioperative period,and the impact on progression-free survival/survival and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ① Age ≥18 years old, \\<80 years old, male or female; ② The patient signed the informed consent and volunteered to participate in the study; ③ Patients with malignant tumors (laryngeal cancer, esophageal cancer, lung cancer, gastric cancer, colorectal cancer, liver cancer, pancreatic cancer) evaluated by clinical stage II to IV; ④ Patients undergoing tumor surgery; ⑤ Patients with NRS 2002 score ≥ 3 after management risk screening; ⑥ Basic reading and communication skills; ⑦ Have the ability to act; Patients with a life expectancy greater than 6 months;\n\nExclusion Criteria:\n\n* ① Acute onset of chronic disease; ② Pregnant or lactating women; ③ Patients with contraindications and no tumor surgery; (4) Patients with malignant tumors (laryngeal cancer, esophageal cancer, lung cancer, stomach cancer, colorectal cancer, liver cancer, pancreatic cancer) were confirmed by pathology and/or cytology after surgery; ⑤ Combined with cognitive dysfunction, mental disorder, consciousness disorder or unwillingness to cooperate; ⑥ Patients with severe gastrointestinal symptoms, liver and renal insufficiency (alanine aminotransferase ALT≥2 times the upper limit of normal value; Total bilirubin Tbil≥2 times the upper limit of normal value; Creatinine Cr≥2 times the upper limit of normal value); (7) Patients with two or more types of tumors; Long-term bed rest, hemiplegia or coma; ⑨ Severe dysfunction of liver, kidney and other organs; ⑩ Allergy or intolerance to nutrients or their main components (such as lactose or galactose, etc.).'}, 'identificationModule': {'nctId': 'NCT06059560', 'briefTitle': 'Nutritional Intervention for Patients With Multiple Cancer Types', 'organization': {'class': 'OTHER', 'fullName': 'First Hospital of China Medical University'}, 'officialTitle': 'An Open, Real-world Study of the Effects of Perioperative Intensive Nutritional Management on Short-term Quality of Life and Long-term Life Outcomes in Patients With Multiple Cancers', 'orgStudyIdInfo': {'id': 'FirstHCMU_nutrient'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'interventian group', 'description': 'Intensive nutritional interventions based on real-world treatments', 'interventionNames': ['Dietary Supplement: Nutritional therapy']}, {'type': 'EXPERIMENTAL', 'label': 'control group', 'description': 'Nutritional guidance and education based on real world treatments', 'interventionNames': ['Dietary Supplement: Nutritional therapy']}], 'interventions': [{'name': 'Nutritional therapy', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Intensive nutritional therapy based on real world therapy', 'armGroupLabels': ['control group', 'interventian group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Kai Li, MD', 'role': 'CONTACT', 'email': 'cmu1h_likai@163.com', 'phone': '+8613998245233'}], 'facility': 'The First Affiliated Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'centralContacts': [{'name': 'Kai Li, MD', 'role': 'CONTACT', 'email': 'cmu1h_likai@163.com', 'phone': '8613998245233'}], 'overallOfficials': [{'name': 'Kai Li, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'First Hospital of China Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Hospital of China Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Director of surgical Oncology', 'investigatorFullName': 'Kai Li', 'investigatorAffiliation': 'First Hospital of China Medical University'}}}}