Pilot study for evaluation of the effect of AHCC(R) on reducing lenvatinib-related adverse events in patients.

JRCT ID: jRCTs011230061

Registered date:08/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: hepatocellular carcinoma
• Date of first enrollment: 08/03/2024
• Target sample size: 129
• Study type: Interventional
• Intervention(s): Oral intake of AHCC(R)

Outcome(s)

• Primary Outcome: Rates of dose reduction and discontinuation within 12 weeks of chemotherapy (lenvatinib) in patients with unresectable hepatocellular carcinoma.

Secondary Outcome

1) Frequency of adverse events (CTCAE ver. 5.0)
2) Occurrence of adverse events (questionnaire)
3) Total dose of lenvatinib
4) Tumour markers (AFP, PIVKA-II)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 95age old
• Gender: Both

Include criteria

1) Male and female who are between the ages of 18 and 94 upon date of resistration for the study.
2) Patients with unresectable hepatocellular carcinoma.
3) Patients who are able to take orally.
4) Patients who scheduled to start lenvatinib administration.
5) Patients who have been fully informed about their participation in this study, and who have given written consent of their own free will based on sufficient understanding.

Exclude criteria

1) Patients with ECOG Performance Status of 2 or higher.
2) Patients with severe hepatic or renal dysfunction.
3) Patients with severe drug allergy (hypersensitivity).
4) Patients who took mushroom (edible)- or basidiomycete-derived dietary supplements after two mounths (but not multivitamin supplements).
5) Patients with allergies to mushrooms (edible)- or basidiomycete-derived health foods.
6) Patients with a history of gastrectomy or malabsorption syndrome.
7) Patients with a history of psychiatric disorders, central nervous system disorders, or cerebrovascular disorders.
8) Patients with or suspected of having clinically problematic infections.
9) Patients who are pregnant, or who may possibly become pregnant.
10) Patients on immunosuppresants.
11) Patients enrolled in other clinical trials.
12) Patients who, for reasons other than those stated above, have been deemed as incompatible with the study by principal Investigator or subinvestigator.

Related Information

• Primary Sponsor: Taketomi Akinobu
• Source(s) of Monetary Support: Amino Up Co., Ltd.