Gastric Cancer-Related Fatigue
Conditions
Interventions
Control group:Routine treatment
Experimental group:Routine treatment+Orally administered Zini Xiaopi Formula
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Met diagnostic criteria for gastric cancer AND received platinum-based (e.g. oxaliplatin) or fluoropyrimidine-based (e.g. capecitabine) standardized chemotherapy regimens; 2. Diagnosed with spleen qi deficiency syndrome per TCM diagnostic criteria; 3. Met Cancer-Related Fatigue (CRF) diagnostic criteria AND exhibited fatigue symptoms on validated scales; 4. Aged 18-75 years; 5. Expected life expectancy =6 months; 6. Hemoglobin level =90 g/L; 7. Karnofsky Performance Status (KPS) score =60; 8. Demonstrated good compliance and willingness to cooperate with treatment protocols; 9. Voluntarily enrolled and provided signed informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients with a history of allergy to Chinese herbal medicine or inability to tolerate herbal therapy; 2. Concurrent users of hormones or psychostimulants; 3. Pregnant/lactating women or patients with psychiatric disorders; 4. Individuals unable to receive oral administration; 5. Patients with severe acute/chronic diseases of cardiac pulmonary hepatic renal immune or hematopoietic systems or showing significant organ dysfunction: - Serum creatinine >1.5×ULN (upper limit of normal) - ALT or AST =5×ULN - Total bilirubin >1.5×ULN 6. Oral/abdominal discomfort within 4 weeks prior to saliva collection with concomitant antibiotic/probiotic use.1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Brief Fatigue Inventory;TCM syndrome score scale;Piper Fatigue Revised Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30) Version 3.0;Karnofsky Performance Status scales;Pittsburgh sleep quality index; | — |
Countries
China
Contacts
Public ContactDehou Deng
Zhejiang Cancer Hospital
Outcome results
None listed