Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT06830018
Status:
RECRUITING
Last Update Posted:
2025-02-17
First Post:
2025-02-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nanocrystalline Megestrol for First-line Treatment of Advanced Gastric or Colorectal Cancer With Cancer-related Fatigue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 76}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-14', 'studyFirstSubmitDate': '2025-02-11', 'studyFirstSubmitQcDate': '2025-02-14', 'lastUpdatePostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the difference in improvement of fatigue as measured with the Revised Piper Fatigue Scale-Chinese Version (RPFS-CV).', 'timeFrame': 'week 6'}, {'measure': 'the difference in improvement of appetite based on A/CS-12 assessment', 'timeFrame': 'week 6'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cancer-related fatigue， cancer-caused fatigue，fatigue，appetite stimulants', 'gastric cancer，colorectal cancer，gastrointestinal tumor，cancer，tumor，carcinoma，', 'nano-crystalline megestrol acetate，megestrol，megestrol acetate，', 'antineoplastic agents, hormonal，central nervous system stimulants，appetite stimulants'], 'conditions': ['Cancer-related Fatigue， Gastric Cancer，Colorectal Cancer，Nano-crystalline Megestrol Acetate，Megestrol Acetate，First-line Treatment']}, 'descriptionModule': {'briefSummary': 'This study is a prospective, randomized, parallel-controlled clinical trial, with the primary objective to evaluate the efficacy and safety of nano-crystalline megestrol acetate combined with standard treatment compared to standard treatment alone for the first-line treatment of patients with cancer-related fatigue in gastric or colorectal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years and ≤75 years.\n* Eastern Cooperative Oncology Group (ECOG) physical status score of 0-2.\n* Expected survival ≥ 6 months.\n* Locally advanced or metastatic gastric/gastroesophageal junction (G/GEJ) adenocarcinoma or colorectal adenocarcinoma not amenable to radical treatment with histologic or cytologic confirmation.\n* No prior systemic systemic antitumor therapy for gastric/gastroesophageal junction (G/GEJ) adenocarcinoma or colorectal cancer.\n* Have at least one measurable tumor lesion according to RECIST v1.1.\n* Compliance with a Fatigue Visual Analog Scale (VAS) score of ≥ 4 (consistent with moderate or severe fatigue).\n* Complain of anorexia.\n* Good organ function as determined by the following requirements.\n\nExclusion Criteria:\n\n* Suffered significant surgery or traumatic injuries within the past 1month.\n* Having any condition that affects gastrointestinal absorption, such as dysphagia, malabsorption, or uncontrollable vomiting.\n\ncurrently undergoing tube feeding or parenteral nutrition.\n\n* Suffering from anorexia due to neurosis, mental illness, or difficulty eating due to pain.\n* Received erythropoietin or blood transfusion within the past 1month.\n* Comorbidities such as serious cerebrovascular, heart, kidney, or liver disease.\n* A history of hypersensitivity to the components of the trial medication.\n* Other conditions that were considered inappropriate as determined by the investigators.'}, 'identificationModule': {'nctId': 'NCT06830018', 'briefTitle': 'Nanocrystalline Megestrol for First-line Treatment of Advanced Gastric or Colorectal Cancer With Cancer-related Fatigue', 'organization': {'class': 'INDUSTRY', 'fullName': 'Changchun GeneScience Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Multicenter, Prospective, Randomized, Parallel-controlled Clinical Study of Nano-crystalline Megestrol Acetate Combined With Standard Treatment Versus Standard Treatment Alone for the First-line Treatment of Patients With Cancer-related Fatigue In Gastric Or Colorectal Cancer', 'orgStudyIdInfo': {'id': 'MGA- Fatigue-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nano-crystalline Megestrol Acetate Oral Suspension + Standard Therapy', 'interventionNames': ['Drug: Nano-crystalline Megestrol Acetate Oral Suspension', 'Combination Product: Standard Treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Therapy', 'interventionNames': ['Combination Product: Standard Treatment']}], 'interventions': [{'name': 'Nano-crystalline Megestrol Acetate Oral Suspension', 'type': 'DRUG', 'description': 'Nano-crystalline Megestrol Acetate Oral Suspension, with a specification of 125 mg/mL, the study group takes 5 mL orally per day (625 mg/day), and continues medication; after completing the treatment cycle, patients who are assessed by the researchers as suitable for continued treatment may continue to receive therapy.', 'armGroupLabels': ['Nano-crystalline Megestrol Acetate Oral Suspension + Standard Therapy']}, {'name': 'Standard Treatment', 'type': 'COMBINATION_PRODUCT', 'description': 'Standard Treatment，First-line treatment (chemotherapy + immunotherapy/targeted therapy)', 'armGroupLabels': ['Nano-crystalline Megestrol Acetate Oral Suspension + Standard Therapy', 'Standard Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110000', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'facility': 'The First Hospital Of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'centralContacts': [{'name': 'Xiujuan Qu', 'role': 'CONTACT', 'email': 'xjqu@cmu.edu.cn', 'phone': '024-83281560'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changchun GeneScience Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}