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Clinical study for investigation of immunostimulatory effect of AHCC(R) on pediatric cancer patients

Open-label exploratory clinical study for investigation of immunostimulatory effect of AHCC(R) on patients with refractory pediatric cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs011240079
Enrollment
20
Registered
2025-03-27
Start date
2025-09-26
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

Childhood solid cancer

Interventions

Sponsors

Cho Yuko
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients in first remission, second remission, or terminal stage of pediatric solid tumors 2) Patients more than 30 days and less than 60 days since the last treatment date (the later of the last administration of anticancer drug or the date of completion of irradiation) 3) Patients who are able to take oral intake 4) Patients with age between 3 and 18 at informed consent 5) Person who has given free written consent based on a full understanding of the consent after receiving a full explanation of this study using a consent document. The written consent is defined as the person's written consent if the participant is 18 years of age, the person's and representative's written consent if the participant is 16 or 17 years of age, or the representative's written consent if the participant is younger than 16 years of age. If the participant is older than seven and younger than 17, informed consent must also be obtained in person using an age-appropriate consent form.

Exclusion criteria

Exclusion criteria: 1) Patients with serious hepatic or renal dysfunction. 2) Patients with serious drug allergy (hypersensitivity). 3) Patients receiving immunosuppressive drugs or immunosuppressive doses of corticosteroids . 4) Patients who are continuously taking immunostimulant supplements. 5) Patients who are allergic to mushrooms (edible) or health foods derived from mycelia. 6) Patients with history of gastrectomy or malabsorption syndrome. 7) Patients who have history of mental disorder, central nervous system disorder, or cerebrovascular disorder. 8) Patients who have or are suspected to have a clinically problematic infectious disease. 9) Patients who enrolled in another clinical trial. 10) Patients who are pregnant, or who may possibly become pregnant. 11) Patients undergoing terminal care whose prognosis is considered to be less than one month. 12) Patients who, for reasons other than those stated above, have been deemed as incompatible with the study by the physician-in-charge.

Design outcomes

Primary

MeasureTime frame
Immune index

Secondary

MeasureTime frame
1) Tumor markers 2) Quality of life 3) Infection 4) Primary disease status 5) Safty

Contacts

Public ContactAtsushi Manabe

Hokkaido University Graduate School of Medicine

atmanabe@med.hokudai.ac.jp+81-11-706-5954

Outcome results

None listed

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