colorectal cancer?
Conditions
Interventions
TCM group:Kidney-Tonic Detoxifying Formula combined with basic therapy (chemotherapy and targeted therapy)
Control group:Conventional therapy (chemotherapy and targeted therapy)
Sponsors
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine?
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Patients with pathologically confirmed ??Stage IV (TNM classification) colorectal cancer??; 2.Meeting diagnostic criteria for ??Kidney Deficiency Syndrome?? in Traditional Chinese Medicine (TCM); 3.Aged ??18–75 years?? with an ??ECOG performance status (0–2)?? or ??Karnofsky Performance Status (KPS) =70??; 4.No use of ??antibiotics probiotics proton pump inhibitors (PPIs) or hormonal medications?? (known to significantly affect microbiota) within ??2 weeks prior to enrollment??; 5.??Good compliance?? with the ability to understand the study requirements and provide ??written informed consent??.
Exclusion criteria
Exclusion criteria: 1.Patients with ??concurrent primary tumors in other organs??; 2.Those with ??severe cardiovascular/cerebrovascular diseases major psychiatric disorders or cognitive impairment?? that may affect questionnaire responses; ??3.Pregnant or lactating women??; 4.Current participation or ??participation in other drug clinical trials within 4 weeks??.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Traditional Chinese Medicine Syndrome Scoring; | — |
Secondary
| Measure | Time frame |
|---|---|
| ??Karnofsky Performance Status??;?Changes in immune cell CD4/CD8 ratios and validation factors before and after treatment?; ??Progression-Free Survival??; ??European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core - 30;Oral-Gut Microbiota?;Gut Microbial Metabolites?; | — |
Countries
China
Contacts
Public ContactHuirong Zhu
No. 528 Zhangheng Road Pudong New Area Shanghai Shuguang Hospital?
Outcome results
None listed