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

NCT ID: NCT07178093

Last Updated: 2025-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Hepatocellular Carcinoma Transarterial Chemoembolization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized double blind placebo controlled study
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Antrodia cinnamomea group

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.

Group Type EXPERIMENTAL

Antrodia cinnamomea

Intervention Type DIETARY_SUPPLEMENT

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.

Placebo group

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.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Antrodia cinnamomea group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taichung Tzu Chi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yu, Cheng-Chan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Taichung Tzu-Chi Hospital

Taichung, Taiwan, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yu Cheng-Chan, Dr

Role: CONTACT

+886-0436060666 ext. 3040

Yu Cheng-Chan, MD

Role: CONTACT

+886-0436060666 ext. 3040

Facility Contacts

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Cheng-Chan Yu, Dr

Role: primary

+886-4-36060666 ext. 3040

Other Identifiers

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REC111-54

Identifier Type: -

Identifier Source: org_study_id

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