Does add-on therapy with Chinese herb medicine Bo-Er-Ning capsule (BENC) improve the outcomes of gastric cancer patients?

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2018
INTERVENTION: All patients with advanced GC treated by FP regimen (Tegafur + Cisplatin) in Zhangqiu People's Hospital of Shandong were enrolled for this clinical study by a doctor participating in the study and randomly divided into two groups by another doctor. Among those, 58 patients received BENC accompanying FP regimen (trial group), while 54 patients received FP regimen alone (control group). Treatment regimen for control group: Tegafur 40 60mg, oral administration, two times a day, from day 1 to day 14 and Cisplatin 40mg, intravenous infusion administration, from day 1 to day 3. Treatment regimen for trial group: BENC 4 capsules, taken orally three times a day (with warm water half an hour after a meal) for 14 days (from day 1 to day 14), accompanying Tegafur and Cisplatin treatment (the same drug dosage and usage as the control group). Both groups were evaluated after 3 cycles (both groups take 21 days as one cycle) of chemotherapy (14 days of treatment and 7 days of rest). CONDITION: Advanced gastric cancer ; Cancer ; Stomach, unspecified PRIMARY OUTCOME: Measured at week 9 (after 3 cycles of chemotherapy):; 1. Appetite, assessed by filling out answer sheets ; 2. Karnofsky performance score (KPS), assessed by filling out answer sheets ; 3. Body weight, measured using a weight scale SECONDARY OUTCOME: 3‐year overall survival: patients followed up by clinic visit, phone, or mail at least once every 6 months starting from day 1 after the treatment INCLUSION CRITERIA: 1. Age from 25 to 75 years 2. All patients were pathologically confirmed for stage IV or postoperative recurrence and metastasis GC 3. Karnofsky performance score (KPS) = 80 4. No previous anticancer therapy 5. No dysfunction of heart, liver, lung and kidney
Epistemonikos ID: 1592d74e9a056cd9a37043de8d97584973fadfd7
First added on: Aug 24, 2024