Effects of Antrodia Cinnamomea on the Hepatoma Patients After Transcatheter Hepatic Artery Chemoembolization

Taichung Tzu Chi Hospital

Status: Enrolling

Conditions: Transarterial Chemoembolization; Hepatocellular Carcinoma

Treatments: Dietary Supplement: placebo; Dietary Supplement: Antrodia cinnamomea

Study type: Interventional

Funder types: Other

Identifiers

NCT07178093

REC111-54

Details and patient eligibility

About

Effects of Antrodia cinnamomea on the hepatoma patients after Transcatheter hepatic artery chemoembolization

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Antrodia cinnamomea group

Experimental 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.

Treatment:

Dietary Supplement: Antrodia cinnamomea

Placebo group

Placebo Comparator 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.

Treatment:

Dietary Supplement: placebo