Colorectal cancer
Conditions
Interventions
Control Group:Administer adjuvant chemotherapy using the FOLFOX regimen.
Probiotic group:In addition to the chemotherapy in the control group, Bifidobacterium triple live bacteria capsules were additionally administered.
Original Formula Group:In addition to the chemotherapy in the control group, Jianpi Bushen Decoction was administered.
New dosage form group:In addition to the chemotherapy of the control group, Jianpi Bushen Formula optimized granules were administered.
Sponsors
Shanghai Putuo District People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: The patient meets the Western medical diagnostic criteria for colorectal cancer (including colon cancer and rectal cancer) and is a stage II-III colorectal cancer patient within 1 month after surgery; The patient meets the diagnostic criteria for "Spleen-Kidney Deficiency Syndrome" in Traditional Chinese Medicine; The patient is aged 18-75 years, with no restriction on gender; The patient has a Karnofsky Performance Status (KPS) score of =70; The patient voluntarily participates in this study and has signed the informed consent form.
Exclusion criteria
Exclusion criteria: Combined severe hepatic and renal dysfunction (ALT/AST > 3 times the upper limit of normal, creatinine > 1.5 times the upper limit of normal), cardiac insufficiency (NYHA classification = III), or hematological disorders; History of treatment with immunosuppressants, biologics, or targeted therapies (excluding adjuvant therapy after surgery); Allergy to the herbal components of the Jianpi Bushen formula (e.g., Astragalus, Psoralea, Atractylodes, etc.) or chemotherapy drugs (e.g., oxaliplatin, 5-FU, etc.); Presence of uncontrolled complications such as intestinal obstruction, gastrointestinal bleeding, or peritoneal infection; Coexistence of other malignant tumors or severe mental disorders; Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cancer-related fatigue relief rate;Improvement rate of anorexia symptoms;Cumulative recurrence metastasis rate;The overall effective rate of therapeutic effects on the syndrome of Spleen-Kidney Deficiency; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival rate;Progression-Free Survival;Incidence rate of adverse reactions to chemotherapy;Patient quality of life achievement rate;Adherence to New Dosage Form Treatment; | — |
Countries
China
Contacts
Public ContactYin Peihao
Shanghai Putuo District People's Hospital
Outcome results
None listed