Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-01-09 @ 8:58 AM
Study NCT ID:
NCT06500234
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutrition Impact on Immunotherapy of Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D011475', 'term': 'Prosthesis Failure'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019290', 'term': 'Megestrol Acetate'}, {'id': 'D000077152', 'term': 'Olanzapine'}], 'ancestors': [{'id': 'D008535', 'term': 'Megestrol'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Malnourished patients with megestrol acetate 160mg oral, olanzapine 2.5mg oral, everyday during the immunotherapy course or intolerable.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-12', 'studyFirstSubmitDate': '2024-07-04', 'studyFirstSubmitQcDate': '2024-07-12', 'lastUpdatePostDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ORR', 'timeFrame': '12 months', 'description': 'overall response rate'}], 'secondaryOutcomes': [{'measure': 'PFS', 'timeFrame': '12 months', 'description': 'profression-free survival'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nutrition Disorders', 'Immunotherapy', 'Cancer', 'Survival, Prosthesis']}, 'descriptionModule': {'briefSummary': 'This study investigates nutritional status and outcomes of immuntherapy in cancer patients.', 'detailedDescription': "Studies have shown that more than half of the patients with cancer are also malnourished at diagnosis. This increases patients' risk of complications associated with the treatment as well as the abandonment of care, as well as decrease the level of survival rates."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of cancer, malnutrition Age \\>18 years Performance status ECOG of 0 or 2. Life expectancy ≥ 6 months. At least one lesion measurable as defined by standard imaging criteria for the patient's tumor type (RECIST v1.1) Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment Postmenopausal or evidence of non-childbearing status for women of childbearing potential Patient is willing and able to comply with the protocol for the duration of the study.\n\nFor all oral medications patients must be able to comfortably swallow capsules;\n\nExclusion Criteria:\n\n* Patients unable to swallow orally administered medication and patients with Impairment of gastrointestinal (GI) function or GI disease that may significantly alter drug absorption of oral drugs History of allogenic organ, bone marrow or double umbilical cord blood transplantation.\n\nActive or prior documented autoimmune or inflammatory disorders Uncontrolled intercurrent illness or patient considered a poor medical risk due to a serious, uncontrolled medical disorder, including but not limited to, ongoing or active infection, symptomatic congestive heart failure Currently taking medications with known risk of prolonging the QT interval or inducing Torsades de Pointes."}, 'identificationModule': {'nctId': 'NCT06500234', 'briefTitle': 'Nutrition Impact on Immunotherapy of Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Qingdao Central Hospital'}, 'officialTitle': 'Phase III Study on the Relation of Nutrition and Immunotherapy of Cancer Patients', 'orgStudyIdInfo': {'id': 'KY202400918'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'megestrol acetate-olanzapine', 'description': 'Megestrol acetate 160 mg, oral, everyday Olanzapine 2.5 mg, oral everyday', 'interventionNames': ['Drug: Megestrol Acetate and olanzapine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': 'Starch powder 50 mg, oral, everyday,', 'interventionNames': ['Drug: Starch powder 50 mg']}], 'interventions': [{'name': 'Megestrol Acetate and olanzapine', 'type': 'DRUG', 'description': 'megestrol acetate, 160 mg, oral everyday; olanzapine 2.5 mg, oral everyday', 'armGroupLabels': ['megestrol acetate-olanzapine']}, {'name': 'Starch powder 50 mg', 'type': 'DRUG', 'description': 'Starch powder 50 mg, oral, everyday', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '266042', 'city': 'Qingdao', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'KEKE NIE, MD', 'role': 'CONTACT', 'email': 'NIEKEKEQD@163.COM', 'phone': '68665078'}, {'name': 'Keke Nie, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Qingdao Central Hospital', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}], 'centralContacts': [{'name': 'Keke Nie, MD', 'role': 'CONTACT', 'email': 'niekeke@uor.edu.cn', 'phone': '53268665078'}], 'overallOfficials': [{'name': 'chunling zhang, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Qingdao Central Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qingdao Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}