Hepatocellular Carcinoma, Transarterial Chemoembolization
Conditions
Keywords
hepatocellular carcinoma (HCC), viral hepatitis, Antrodia cinnamomea, post-TACE syndrome, hepatocellular carcinoma, antrodia cinnamomea, post-TACE syndrome
Brief summary
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_SUPPLEMENTAntrodia 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_SUPPLEMENTplacebo
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.
Sponsors
Taichung Tzu Chi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Randomized double blind placebo controlled study
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of serum Aspartate Transaminase (AST) level after TACE | 28 days | The serum Aspartate Transaminase (AST) levels after TACE day 1, day 3, day 7, day 28 are compared to the baseline. |
| Changes of serum Alanine Aminotransferase (ALT) level after TACE | 28 days | The serum Alanine Aminotransferase (ALT) levels after TACE day 1, day 3, day 7, day 28 are compared to the baseline. |
| Changes of serum total bilirubin level after TACE | 28 days | The serum total bilirubin levels after TACE day 1, day 3, day 7, and day 28 are compared to the baseline |
| Changes of serum albumin level after TACE | 28 days | The serum albumin levels after TACE day 1, day 3, day 7, and day 28 are compared to the baseline |
| Changes of prothrombin time after TACE | 28 days | The prothrombin time after TACE day 1, day 3, day 7, and day 28 are compared to the baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of the quality of life | 28 days | 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. |
Countries
Taiwan
Contacts
Primary ContactYu Cheng-Chan, Dr
Backup ContactYu Cheng-Chan, MD
Outcome results
None listed