Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 11:17 PM
Study NCT ID:
NCT07178093
Status:
RECRUITING
Last Update Posted:
2025-09-17
First Post:
2023-04-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Antrodia Cinnamomea on the Hepatoma Patients After Transcatheter Hepatic Artery Chemoembolization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized double blind placebo controlled study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2023-04-28', 'studyFirstSubmitQcDate': '2025-09-16', 'lastUpdatePostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of serum Aspartate Transaminase (AST) level after TACE', 'timeFrame': '28 days', 'description': 'The serum Aspartate Transaminase (AST) levels after TACE day 1, day 3, day 7, day 28 are compared to the baseline.'}, {'measure': 'Changes of serum Alanine Aminotransferase (ALT) level after TACE', 'timeFrame': '28 days', 'description': 'The serum Alanine Aminotransferase (ALT) levels after TACE day 1, day 3, day 7, day 28 are compared to the baseline.'}, {'measure': 'Changes of serum total bilirubin level after TACE', 'timeFrame': '28 days', 'description': 'The serum total bilirubin levels after TACE day 1, day 3, day 7, and day 28 are compared to the baseline'}, {'measure': 'Changes of serum albumin level after TACE', 'timeFrame': '28 days', 'description': 'The serum albumin levels after TACE day 1, day 3, day 7, and day 28 are compared to the baseline'}, {'measure': 'Changes of prothrombin time after TACE', 'timeFrame': '28 days', 'description': 'The prothrombin time after TACE day 1, day 3, day 7, and day 28 are compared to the baseline.'}], 'secondaryOutcomes': [{'measure': 'Improvement of the quality of life', 'timeFrame': '28 days', 'description': 'European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire (EORTC QLQ-C30 questionnaire) has 30 items, covering both general health status and cancer-related symptoms. Each item is scored on a 4-point Likert scale (1 = "Not at all" to 4 = "Very much"), except for the global health/QoL items, which use a 7-point scale (1 = "Very poor" to 7 = "Excellent"). The differences of the scores after TACE are recorded.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hepatocellular carcinoma (HCC), viral hepatitis, Antrodia cinnamomea, post-TACE syndrome', 'hepatocellular carcinoma', 'antrodia cinnamomea', 'post-TACE syndrome'], 'conditions': ['Hepatocellular Carcinoma', 'Transarterial Chemoembolization']}, 'descriptionModule': {'briefSummary': 'Effects of Antrodia cinnamomea on the hepatoma patients after Transcatheter hepatic artery chemoembolization', 'detailedDescription': 'Hepatocellular carcinoma (HCC) accounts for 7% of all cancers worldwide and is the most common, primary liver malignancy globally. It is the second leading cause of cancer-related mortality in Taiwan. Most of the patients with HCCs are associated with hepatitis virus B or C infection, and combined with abnormal liver function or liver cirrhosis. The treatment of HCC includes curative treatment, including surgical resection, liver transplantation, and radiofrequency ablation. Non-curative treatment includes Transcatheter hepatic artery chemoembolization or medical therapy, such as target therapies or immunotherapies. Some patients suffered from post-TACE syndrome, e.g., abdominal pain, nausea, fever, or impaired liver function, after TACE. The clinical application was limited by the possibility of liver function deterioration. There is no standard treatment for the post-TACE syndrome currently. Therapies capable of liver protection could enhance the safety and effect of TACE.\n\nAntrodia cinnamomea (AC) is a medicinal fungal species that has been widely used as a healthy food in Taiwan for the treatment of diverse health-related conditions, in recognition of its anticancer, hepatoprotective, anti-inflammatory, antidiabetic and neuroprotective activities. The properties of antitumor and hepatoprotective make A. cinnamomea extract or its major compounds an ideal candidate for enhancing the treatment effect for HCC.\n\nMany cancer patients in Taiwan took Antrodia cinnamomea products during the course of therapies. In this study, we want to elucidate the effect of Antrodia cinnamomea on the hepatoma patients after Transcatheter hepatic artery chemoembolization, such as the improvement of post-TACE syndrome ( liver function impairment, fever, nausea, and abdominal pain), the quality of life, and hospital stay, etc.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sign the informed consent form\n* Aged between 20 and 80\n* Child-Pugh score class A, B\n* Serum bilirubin level ≤ 1.5 times the upper limit of normal, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels ≤ 2 times the upper limit of normal\n\nExclusion Criteria:\n\n* Unwillingness to sign the informed consent form\n* Child-Pugh score class C\n* Patients with main portal vein thrombosis\n* Patients with diffuse liver tumors\n* Those who are allergic to the contrast medium\n* Those with abnormal coagulation function\n* Those with severe dysfunction of brain, heart and lung\n* Patients with severe renal dysfunction (except those receiving renal dialysis)\n* Unable to cooperate\n* Those with uncontrolled arrhythmia and unstable blood pressure\n* Some patients with abnormal thyroid function\n* Any other contraindications such as active gastrointestinal bleeding, refractory ascites, or severe portal hypertension\n* Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT07178093', 'briefTitle': 'Effects of Antrodia Cinnamomea on the Hepatoma Patients After Transcatheter Hepatic Artery Chemoembolization', 'organization': {'class': 'OTHER', 'fullName': 'Taichung Tzu Chi Hospital'}, 'officialTitle': 'Effects of Antrodia Cinnamomea on the Hepatoma Patients After Transcatheter Hepatic Artery Chemoembolization', 'orgStudyIdInfo': {'id': 'REC111-54'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Antrodia cinnamomea group', 'description': "This group will use Antrodia cinnamomea on the hepatoma patients after Transcatheter hepatic artery chemoembolization. The choice of chemical drug dosage for the patient's hepatic artery embolization is evaluated according to the size of the tumor, which can be divided into 1. Epirubicin 10mg + Lipiodol 10ml 2. Epirubicin 20mg + Lipiodol 10ml; oral dosage form of Antrodia cinnamomea is single capsule/500mg, each oral dose is 2 capsules/1000mg. The experiment lasted for 11 days, and patients were required to take Kangjian Antrodia cinnamomea 3 days before embolization, the day of embolization to the 7th day after surgery, once a day in the morning and evening after meals, 2 capsules each time.", 'interventionNames': ['Dietary Supplement: Antrodia cinnamomea']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': "This group will use placebo on the hepatoma patients after Transcatheter hepatic artery chemoembolization. The choice of chemical drug dosage for the patient's hepatic artery embolization is evaluated according to the size of the tumor, which can be divided into 1. Epirubicin 10mg + Lipiodol 10ml 2. Epirubicin 20mg + Lipiodol 10ml; oral dosage of placebo is 2 capsules twice daily. The experiment lasted for 11 days, and patients were required to take placebo 3 days before embolization, the day of embolization to the 7th day after surgery, once a day in the morning and evening after meals, 2 capsules each time.", 'interventionNames': ['Dietary Supplement: placebo']}], 'interventions': [{'name': 'Antrodia cinnamomea', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Antrodia cinnamomea group'], 'description': 'The experiment lasted for 11 days, and patients were required to take Kangjian Antrodia cinnamomea 3 days before embolization, the day of embolization to the 7th day after surgery, once a day in the morning and evening after meals, 2 capsules each time.', 'armGroupLabels': ['Antrodia cinnamomea group']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The experiment lasted for 11 days, and patients were required to take placebo 3 days before embolization, the day of embolization to the 7th day after surgery, once a day in the morning and evening after meals, 2 capsules each time.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '406', 'city': 'Taichung', 'state': 'Taiwan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Cheng-Chan Yu, Dr', 'role': 'CONTACT', 'email': 'jefferyu@gmail.com', 'phone': '+886-4-36060666', 'phoneExt': '3040'}], 'facility': 'Taichung Tzu-Chi Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Yu Cheng-Chan, Dr', 'role': 'CONTACT', 'email': 'jefferyu@gmail.com', 'phone': '+886-0436060666', 'phoneExt': '3040'}, {'name': 'Yu Cheng-Chan, MD', 'role': 'CONTACT', 'email': 'jefferyu@gmail.com', 'phone': '+886-0436060666', 'phoneExt': '3040'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taichung Tzu Chi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yu, Cheng-Chan', 'investigatorAffiliation': 'Taichung Tzu Chi Hospital'}}}}