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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs011230061

Enrollment

129

Registered

2024-03-08

Start date

2024-05-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatocellular carcinoma

Interventions

Oral intake of AHCC(R)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
Rates of dose reduction and discontinuation within 12 weeks of chemotherapy (lenvatinib) in patients with unresectable hepatocellular carcinoma.	—

Secondary

Measure	Time frame
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)	—

Contacts

Public ContactTakeshi Aiyama

Hokkaido University Graduate School of Medicine

sword0921@hotmail.com+81-11-706-5927

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026