Effects of Antrodia cinnamomea on the hepatoma patients after Transcatheter hepatic artery chemoembolization
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
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.
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.
Taichung Tzu-Chi Hospital
Taichung, Taiwan, Taiwan
RECRUITINGChanges of serum Aspartate Transaminase (AST) level after TACE
The serum Aspartate Transaminase (AST) levels after TACE day 1, day 3, day 7, day 28 are compared to the baseline.
Time frame: 28 days
Changes of serum Alanine Aminotransferase (ALT) level after TACE
The serum Alanine Aminotransferase (ALT) levels after TACE day 1, day 3, day 7, day 28 are compared to the baseline.
Time frame: 28 days
Changes of serum total bilirubin level after TACE
The serum total bilirubin levels after TACE day 1, day 3, day 7, and day 28 are compared to the baseline
Time frame: 28 days
Changes of serum albumin level after TACE
The serum albumin levels after TACE day 1, day 3, day 7, and day 28 are compared to the baseline
Time frame: 28 days
Changes of prothrombin time after TACE
The prothrombin time after TACE day 1, day 3, day 7, and day 28 are compared to the baseline.
Time frame: 28 days
Improvement of the quality of life
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.
Time frame: 28 days
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