A clinical study to evaluate the efficacy of AHCC(R) in reducing bone marrow suppression caused by chemotherapy for urothelial carcinoma.

JRCT ID: jRCTs011240005

Registered date:16/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: urothelial cancer
• Date of first enrollment: 16/04/2024
• Target sample size: 94
• Study type: Interventional
• Intervention(s): Oral intake of AHCC(R)

Outcome(s)

• Primary Outcome: The rate of Grade 3 and 4 of maximum Grade of myelosuppression in each subject who received three or four courses of chemotherapy

Secondary Outcome

A) Cumulative number of G-CSG administered relative to the number of courses of chemotherapy
B) Dose, withdrawal, dose reduction or discontinuation of chemotherapy: relative dose intensity (RDI) and change rate of RDI
C) Neutrophil and platelet counts
D) Alb and CRP levels, and Glasgow Prognostic Score (GPS) based on them
E) Hb and Cre levels, and Cancer and Aging Research Group (CARG) Score based on them
F) Psoas muscle mass index (PMI)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 85age old
• Gender: Both

Include criteria

Subject A
1) Subjects ranging in age from 18 to 84 at informed consent.
2) Subjects diagnosed with locally advanced or metastatic urothelial carcinoma.
3) Subjects scheduled to receive at least three courses of gemcitabine/cisplatin (GC) or gemcitabine/carboplatin (GCb) regimen.
4) Subjects who can make self-judgment and voluntarily gave written informed consent.

Subject B
1) Subjects ranging in age from 20 to 84 at the start of GC or GCb regimen.
2) Subjects diagnosed with locally advanced or metastatic urothelial carcinoma at the start of GC or GCb regimen.
3) Subjects who have received at least three courses of GC or GCb regimen as chemotherapy for locally advanced or metastatic urothelial carcinoma.
4) Subjects who do not offer exclusion.

Exclude criteria

Subject A
1) Subjects with active overlapping cancers (concurrent overlapping cancers) or iatrogenic overlapping cancers with a disease-free interval of five years or less.
2) Subjects receiving immunosuppressive doses of corticosteroids
3) Subjects who are continuously taking immunostimulant supplements.
4) Subjects with psychosis or psychiatric symptoms that make it difficult for them to participate in this study.
5) Subjects with hepatic impairment or renal impairment.
6) Subjects with a serious allergy to drug.
7) Subjects taking dietary supplements derived from mushroom or basidiomycetes since one month before the start of intake test food.
8) Subjects with an allergy to dietary supplements derived from mushroom or basidiomycetes.
9) Subjects with a history of gastrectomy or malabsorption syndrome.
10) Subjects who were pregnant or breast feeding.
11) Subjects with oral intake difficulties.
12) Subjects enrolled in other clinical trials or clinical research.
13) Subjects who were judged not appropriate for this study by the principal investigator or the subinvestigator.

Subject B
1) Patients with active overlapping cancers (concurrent overlapping cancers) or iatrogenic overlapping cancers with a disease-free interval of five years or less at the start of GC or GCb regimen.
2) Subjects who were pregnant or breast feeding at the start of GC or GCb regimen.
3) Subjects enrolled in other clinical trials or clinical research at the start of GC or GCb regimen.
4) Subjects who were judged not appropriate for this study by the principal investigator or the subinvestigator.

Related Information

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