gastric cancer, chemotherapy-induced nausea and vomiting
Conditions
Interventions
MA group:Megestrol acetate 160mg orally once a day d1-3+Palonosetron 0.25mg IV infusion completed within 30 minutes before chemotherapy, d1.
DEX group:Dexamethasone 10 mg d1,5mg d2,d3 orally once a day + palonosetron 0.25 mg IV infusion completed within 30 minutes before chemotherapy d1.
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with gastric cancer through pathological and/or cytological examination; 2. Age between 18 and 75 years old, regardless of gender; 3. The Eastern Cancer Collaborative Group Physical Fitness Score (ECOG) is 0, 1, or 2 points; 4. Patients who have not received radiotherapy or chemotherapy before and plan to receive SOX/CAPEOX chemotherapy with or without immunotherapy; 5. The subjects must have appropriate organ function and be evaluated based on the following laboratory test results (no blood transfusion, granulocyte colony-stimulating factor (G-CSF), or other medical support treatment received within 14 days prior to study drug administration). The laboratory test results within 1 week prior to enrollment meet the following conditions: hemoglobin >= 90g/L; Platelet count (PLT) >= 75 × 109/L; White blood cells (WBC) >= 3.0 × 10^9/L; Neutrophils (ANC) >= 1.5 × 10^9/L; Total bilirubin (TBI) <= 1.5 x Upper limit of normal value (UNL); Blood creatinine (Cr) <= 1.5 x upper limit of normal value; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5 × UNL (<= 5 × UNL if there is liver metastasis); 6. Able to read, understand, and complete questionnaire surveys and diaries; 7. The patient voluntarily participates and is able to understand the research procedure and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Nausea or vomiting occurred within 24 hours prior to enrollment; 2. Persistent vomiting caused by gastrointestinal obstruction or other unknown reasons; 3. Pregnant or lactating women; 4. Patients with brain metastases; 5. Known central nervous system diseases (such as epilepsy); 6. Severe cognitive impairment; 7. Known to be allergic to dexamethasone, medroxyprogesterone acetate, or other basic antiemetic drugs used in this study; 8. Patients with severe uncontrollable infection, electrolyte disorder, diabetes, uncontrollable peptic ulcer, and a past history of cortisol treatment; 9. Patients with known arrhythmias, uncontrolled congestive heart failure, and acute myocardial infarction in the past six months; 10. Merge active HIV, viral hepatitis, and tuberculosis patients; 11. Accept other medications that may affect the antiemetic effect, such as PPI, H2 receptor blockers, amphotericin, and sedatives; 12. Unable to take or absorb oral medication; 13. Received treatment with other investigational drugs 4 weeks before and after admission. 14. Patients with contraindications to the use of medroxyprogesterone acetate, dexamethasone, or other basic antiemetic drugs used in this study, such as those with severe thrombophlebitis, thromboembolic disease, severe liver dysfunction, and hypercalcemia caused by bone metastasis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The complete response (CR) rate throughout the entire stage (i.e. 0-120 hours after the start of SOX/CAPEOX administration). ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event, AE;European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30, EORTC QLQ-C30;European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Stomach 22, EORTC QLQ-STO22; | — |
Countries
China
Contacts
Public ContactHongfeng Gou
West China Hospital of Sichuan University
Outcome results
None listed