Effects of Antrodia Cinnamomea on the Hepatoma Patients After Transcatheter Hepatic Artery Chemoembolization
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Antrodia cinnamomea, placebo.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma, Transarterial Chemoembolization. Basic parameters: 20 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Effects of Antrodia cinnamomea on the hepatoma patients after Transcatheter hepatic artery chemoembolization
Detailed description
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.
Antrodia 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.
Many 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.
Interventions
- Dietary supplement Antrodia cinnamomea
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. - Dietary supplement placebo
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.
Primary outcome measures
- Changes of serum Aspartate Transaminase (AST) level after TACE [Time frame: 28 days]
- Changes of serum Alanine Aminotransferase (ALT) level after TACE [Time frame: 28 days]
- Changes of serum total bilirubin level after TACE [Time frame: 28 days]
- Changes of serum albumin level after TACE [Time frame: 28 days]
- Changes of prothrombin time after TACE [Time frame: 28 days]
Secondary outcome measures (1)
- Improvement of the quality of life [Time frame: 28 days]
Eligibility criteria
Inclusion criteria
- Sign the informed consent form
- Aged between 20 and 80
- Child-Pugh score class A, B
- 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
Exclusion criteria
- Unwillingness to sign the informed consent form
- Child-Pugh score class C
- Patients with main portal vein thrombosis
- Patients with diffuse liver tumors
- Those who are allergic to the contrast medium
- Those with abnormal coagulation function
- Those with severe dysfunction of brain, heart and lung
- Patients with severe renal dysfunction (except those receiving renal dialysis)
- Unable to cooperate
- Those with uncontrolled arrhythmia and unstable blood pressure
- Some patients with abnormal thyroid function
- Any other contraindications such as active gastrointestinal bleeding, refractory ascites, or severe portal hypertension
- Pregnant or lactating women
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Taichung Tzu-Chi Hospital — Taichung
Identifiers
NCT: NCT07178093 · REC111-54