Cancer-associated sarcopenia
Conditions
Interventions
Shenling Baizhu Powder + Western Medicine Group:Addition of Shenling Baizhu Powder to standard Western medical treatment, one dose daily, taken twice warm (100 mL each time, total 200 mL/day). Herbs a
Control group:Standard Western medical treatment (postoperative chemotherapy and related supportive care)
Sponsors
Tianjin Nankai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged between 18 and 75 years, either gender. 2. Diagnosed based on clinical history, symptoms, signs, and imaging findings as gastrointestinal malignancy confirmed by pathology, with TNM staging meeting one of the following: a. Stage II with high-risk factors (requiring postoperative chemotherapy); b. Stage III. 3. SMI value below the threshold (male: 40.8 cm^2/m^2, female: 34.9 cm^2/m^2), and diagnosed with spleen-stomach qi deficiency pattern according to "Diagnostic and Therapeutic Criteria for Internal Medicine Diseases in Traditional Chinese Medicine · Wei Syndrome". 4. Reduced food intake, but greater than 60% of target feeding amount (compared to preoperative). 5. PG—SGA (Patient-Generated Subjective Global Assessment) score >=4. 6. Organ function is adequate, including: sufficient bone marrow reserve: absolute neutrophil count (segmented and band forms) (ANC) >=1.5×10^9/L, platelets >=100×10^9/L, and hemoglobin >=9 g/dL; liver: bilirubin =80 mL/min. 7. Expected survival >=12 weeks. 8. Able to understand the purpose and potential adverse reactions of the study; patient and family provide informed consent and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Severe malnutrition (weight loss >10% compared to preoperative, or serum albumin <30 g/L, or BMI <18.5 kg/m^2) 2. Presence of severe cardiac, pulmonary, or cerebral diseases 3. Accompanied by chronic hepatitis, cirrhosis, chronic nephritis, renal insufficiency, etc. 4. Accompanied by infection-related fever 5. Uncontrolled diabetes or other metabolic disorders 6. Presence of intestinal obstruction preventing oral or enteral nutrition 7. Patients with known allergy or intolerance to any component of Yiqi Yangxue Formula 8. Alcoholism or drug addiction; pregnancy or lactation; or women of childbearing age refusing contraception 9. Patients with brain metastasis or concurrent other tumors 10. Patients unable to sign or comprehend the informed consent 11. Any other reason, as determined by the investigator, that prevents completion of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skeletal Muscle Index (SMI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Albumin;Prealbumin;Hemoglobin;Silent Information Regulator Transcript 1(SIRT1);Growth/Differentiation Factor-8(GDF-8);Insulin-like Growth Factor-1( IGF-1); | — |
Countries
China
Contacts
Public ContactSui Xiaojun
Tianjin Nankai Hospital
Outcome results
None listed