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

ConditionsHepatocellular CarcinomaTransarterial Chemoembolization
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorTaichung Tzu Chi Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Unwillingness to sign the informed consent form

Child-Pugh score class C

Patients with main portal vein thrombosis

Patients with diffuse liver tumors

Trial design

Design model

Parallel

Treatments tested in this trial

  • Antrodia cinnamomea

    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

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Antrodia cinnamomea groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Changes 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
2

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
3

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
4

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

Secondary outcomes

1

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Taichung Tzu Chi Hospital

Lead sponsor

Source ClinicalTrials.gov
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