Related Experiment Video
Updated: Oct 25, 2026
E-Patient Counseling Trial (E-PACO): Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy
Published on: August 1, 2019
Effectiveness of hochuekkito for colorectal cancer management: protocol for the multicenter randomized controlled
Yoshinaga Okugawa1,2, Takahito Kitajima3,4, Tadanobu Shimura4
1Department of Genomic Medicine, Mie University Hospital, Tsu City, Mie, Japan. yosinaga@med.mie-u.ac.jp.
Background:
Systemic inflammation, a hallmark of cancer, is recognized as a key mechanism underlying malnutrition, sarcopenia, and cancer cachexia. Hochuekkito (TJ-41) is a traditional Japanese Kampo formula composed of ten medicinal plants, and several studies have suggested its anti-inflammatory effects in various diseases. Our recent retrospective study, supported by in vitro experiments, was the first to demonstrate an anti-inflammatory effect of TJ-41 in patients with unresectable or metastatic gastrointestinal cancer, including colorectal cancer (CRC). However, no prospective randomized multicenter clinical trial has evaluated TJ-41 in the palliative setting of malignancies, including CRC.
Methods:
Patients with unresectable or metastatic CRC who have received at least two prior systemic regimens or are intolerant to standard therapy, and who show an elevated C-reactive protein (CRP) level > 0.5 mg/dL on two consecutive occasions within two months before enrollment, will be eligible. After providing written informed consent, patients will be randomly assigned to the treatment group (standard treatment plus TJ-41) or control group (standard treatment alone). Patients in the treatment group will receive oral TJ-41 (Tsumura & Co., Tokyo, Japan) at 7.5 g/day, divided into three doses (2.5 g per dose), before, or between meals for 12 weeks. The primary endpoint is the difference in anti-inflammatory effect between groups, assessed by the change in CRP from baseline to 12 weeks. Secondary endpoints include the effects of TJ-41 on other inflammatory and nutritional parameters; patient-reported symptoms and quality of life (QOL) using QOL-ACD and EORTC QLQ-C30; cytokine-based anti-inflammatory and anticachectic effects using serial blood specimens; interactions with other appetite-stimulating agents or nutritional products; and effects on antitumor efficacy and adverse events (AEs). Each group will include 44 patients, with recruitment planned from July 1, 2024, to December 31, 2026.
Discussion:
This trial will evaluate whether TJ-41 can attenuate systemic inflammation related to host-tumor interactions in patients with unresectable or metastatic CRC.
Trial Registration:
This study was registered in the Japan Registry of Clinical Trials (jRCT) on June 26, 2024 (jRCTs041240051).
