Colorectal Cancer
Conditions
Interventions
Chemotherapy-only group:Conventional chemotherapy regimens (CAPOX/mFOLFOX6)
Combined Chinese medicine group:Conventional chemotherapy regimen (CAPOX/mFOLFOX6) plus TiaoPi AnChang Decoction, one dose per day
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Histopathologically confirmed colorectal cancer with TNM stage high-risk stage II or stage III; 2.Scheduled to receive adjuvant chemotherapy with CAPOX or mFOLFOX6 regimen after curative resection for colorectal cancer; 3.Traditional Chinese Medicine (TCM) syndrome differentiation: Spleen-Kidney Deficiency Syndrome; 4.Age between 18 and 75 years old, with Eastern Cooperative Oncology Group (ECOG) performance status score 0-2; 5.Able to cooperate with stool and blood sample collection, and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Concurrent malignancy (other than colorectal cancer); 2.History of diarrhea or infectious diseases within 4 weeks prior to stool collection; use of antibiotics, proton pump inhibitors (PPIs), gut microbiota-modulating agents, or related medications within 4 weeks prior to enrollment; 3.Any medical history that may impair cognitive function or the ability to provide informed consent; 4.Uncontrolled severe internal diseases, such as heart failure, renal failure, unstable angina pectoris, idiopathic thrombocytopenia, etc.; 5.Current participation in or participation in other clinical trials within 4 weeks prior to enrollment; 6.Pregnant or lactating women, or women planning pregnancy during the study period; 7.Previous neoadjuvant chemoradiotherapy, or planned radiotherapy during chemotherapy; 8.Patients with colostomy or ileostomy after colorectal diversion surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences in intestinal flora structure;Differences in metabolite profiles; | — |
Secondary
| Measure | Time frame |
|---|---|
| Gut microbiota-metabolite association;Incidence and severity of chemotherapy-related adverse reactions;Survival status of study participants; | — |
Countries
China
Contacts
Public ContactCheng Zhiqiang
China-Japan Friendship Hospital
Outcome results
None listed