Colorectal cancer
Conditions
Interventions
research Group:Herbal decoction
control group:control drug
Sponsors
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
60 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1) Age: 60–85 years. 2) Gender: No restrictions. 3) ECOG Performance Status: 0–2. 4) Stage: Pathologically confirmed colorectal cancer, clinically staged as cT3–4/N+. 5) Vital organ function: Complete blood count (CBC) must show hemoglobin = 90 g/L, platelets = 100 × 10 9/L, and neutrophils = 1.5 × 10 9/L; Liver and kidney function markers must meet the following requirements: serum total bilirubin = 1.5 times the upper limit of normal, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 times the upper limit of normal (= 5 times the upper limit of normal if liver metastases are present), and serum creatinine = 1.5 times the upper limit of normal, to ensure that the patient's vital organ functions can withstand the burden of treatment. 6) Meets the diagnostic criteria for the TCM syndrome of deficiency of both qi and blood. 7) Is suitable for receiving FOLFOX6 chemotherapy.
Exclusion criteria
Exclusion criteria: 1) Patients with active autoimmune diseases, severe cardiovascular disease, or central nervous system metastases; these patients have complex conditions and poor prognoses, and their treatment regimens may conflict with this study; 2) Pregnant or breastfeeding women; 3) Patients with allergies to the study drug, psychiatric disorders, or cognitive impairment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Degree of bone marrow suppression; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone marrow recovery time;Cumulative incidence of Grade III/IV myelosuppression;Syndromes in Traditional Chinese Medicine;Quality of life;Fatigue Score;Immune function; | — |
Countries
China
Contacts
Public ContactLiping Qin
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed