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Assessment of Management and Anti-inflammatory Therapy Effectiveness in Colorectal cancer: Randomized Assessment of Supplemental Hochuekkito Therapy (AMATERAS study)

AMATERAS study (AMATERAS study)

Toiyama Yuji

Mie University Hospital

2-174, Edobashi Tsu-city, Mie

ytoi0725@med.mie-u.ac.jp

Okugawa Yoshinaga

Mie University Hospital

2-174, Edobashi Tsu-city, Mie

+81-59-231-5294

amateras@med.mie-u.ac.jp

Recruiting

June. 26, 2024

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1) Participants must have received at least 2 prior systemic therapies in adjuvant and/or metastatic setting (progressed on at least 1 prior regimen in the metastatic setting) or could not tolerate standard treatment
2) Age >= 20 years at the time of informed consent
3) Written informed consent
4) CRP >0.5 mg/dL confirmed on 2 consecutive visits in the past 2 months before enrollment
5) ECOG Performance Status of 0-2
6) Expected to be followed up for >= 12 weeks from enrollment

1) Patients with MSI-High or TMB-High colorectal cancer who are or have been treated with immune checkpoint inhibitors as usual therapy
2) Complications affecting nutrition and inflammation, such as chronic renal dysfunction and autoimmune diseases
3) Patients with infectious diseases requiring antibiotic therapy
4) Ileostomy/colostomy patients with diarrhea that interferes with daily life
5) Patients with a surgery in the past 4 weeks from enrollment, or scheduled a surgery during the study period
6) History of gastrectomy
7) Taking kampo medicine in the previous 2 weeks from visit1 of the study period
8) Inable of oral food intake, due to obstruction/other organic abnormality of the gastrointestinal tract or dysphagia.
9) Inable of taking kampo medicines
10) Moderate or severe hepatic dysfunction (Child-Pugh classification B and C)
11) Patients with any following factors in the past 2 months before enrollment
-1 AST, ALT,GGTP : each items > 5 times the facility standard
-2 T-bil, Cr : each items > 3 times the facility standard
-3 K : K < 3.0 mmol/L or K > 5.5 mmol/L
12) Pleural or ascitic effusion
13) Synchronous or metachronous malignancies
14) Severe complications (cardiac, hematological or metabolic diseases, etc.)
15) History of severe drug hypersensitivity or allergy (especially to Hochuekkito)
16) Pregnant, lactating, possibly pregnancy or patients who plan to getting pregnancy during the study period
17) Judged as ineligible by investigators

Both

Unresectable advanced/recurrent colorectal cancer

Patients are randomly assigned to group A or group B.
group A: The usual treatment for cancer (Hochuekkito non-treatment group).
group B: Orally administration TSUMURA Hochuekkito 7.5 g/day in 3 divided doses before or between meals, adding the usual treatment for cancer (Hochuekkito treatment group).

The anti-inflammatory effects of group A and group B are compared by the CRP change rate at the start of treatment and after 12 weeks.

- The effects of Hochuekkito on inflammatory and nutritional states.
- The effects of Hochuekkito on QOL score.
- The anti-inflammatory and anti-cachexia effects of Hochuekkito at the cytokine level.
- The effects of Hochuekkito in combination with other appetite stimulants and nutrient.
- The effects of Hochuekkito on anti-tumor and adverse anticancer drug reactions.

+81-59-231-5045

Jan. 22, 2024

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