chemotherapy induced delayed nausea (CIDN)
Conditions
Interventions
Experiment group 1:Esomeprazole 20mg day1-4
Experiment group 2:Esomeprazole 40mg day1-4
Control group 1:Esomeprazole 20mg day1
Control group 2:Esomeprazole 40mg day1
Blank control group:None (Routine antiemetic regimen)
Sponsors
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed as malignant tumors by histopathological and/or cytological examinations need chemotherapy with moderate to high risk of nausea and vomiting, and the main nausea-causing drugs are used for one day. 2. Aged 18-75 years, gender is not limited. 3. Physical condition is good: ECOG score is 0-2. 4. The life expectancy is more than 3 months. 5. No major organ dysfunction. Laboratory tests meet the basic requirements of chemotherapy, namely: A) Neutrophil count (>1.5 *10^9/L); B) Platelet count (>90 *109/L); C) HB > 90g/L; D) Serum AST and ALT were less than 1.5 times of the upper limit ULN of normal value (AST and ALT were less than 5.0 times ULN if liver metastasis occurred); E) Total bilirubin < 1.5 times ULN; F) Serum creatinine < 1.5 times ULN; G) The Q-T interval of ECG is less than 450ms; H) Serum electrolytes (sodium, potassium, chlorine and total calcium) were normal. 6. Females of childbearing age should agree to use contraceptive measures within 3 months of the study period and the end of the study; serum or urine pregnancy tests should be negative within 7 days prior to the study and must be non-lactating; males should agree to use contraceptive measures during the study period and within 3 months after the end of the study period. 7. Chemotherapy with a high risk of nausea and vomiting was used, and the main nausea-causing drug was used for one day. 8. Before treatment, there were no obvious abnormalities in blood routine, liver function, kidney function and electrocardiogram, no other contraindications of chemotherapy and no radiotherapy. 9. Patients voluntarily enrolled in the group and signed the informed consent. It has good compliance and can cooperate with the experimental observation.
Exclusion criteria
Exclusion criteria: 1. Patients who participated in other clinical trials within 4 weeks before admission; 2. Patients with gastrointestinal obstruction, brain metastasis and symptoms of intracranial hypertension, or with other potential diseases that can cause and/or aggravate nausea and vomiting, such as metabolic disorders, severe liver and kidney dysfunction, etc.; 3. Patients with degree II to III nausea before chemotherapy; 4. Anyone who received any anti-nausea and vomiting drugs (including glucocorticoids) within 24 hours prior to chemotherapy, except dexamethasone, which was administered in combination on the first day of the trial; 5. Those who are undergoing upper abdominal or cranial radiotherapy within 2-7 days after receiving or using drugs; 6. Patients who cannot eat for any reason; 7. Patients with underlying diseases requiring glucocorticoid therapy; 8. Severe cardiopulmonary dysfunction; 9. Poor compliance or inability to cooperate with treatment and narrate treatment reactions; 10. Allergies to research drugs (Esomeprazole, 5-HT3 receptor antagonists); 11. Pregnant or lactating patients; 12. Patients who used highly vomiting-risk chemotherapeutic drugs within 2 weeks; 13. Other situations in which the researcher did not consider it possible to enroll in the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate of chemotherapy induced nausea;ECOG Physical Status Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete response rate of chemotherapy induced delayed nausea;Total control rate of nausea during total observation period;Remarkable effective rate of nausea;Proportion of patients without obvious nausea;Overall satisfaction of patients with nausea control;Complete control rate of delayed vomiting;Complete control rate of delayed vomiting;Time from the beginning of chemotherapy to the first rescue treatment (h) and the proportion of patients receiving rescue treatment;Safety of experimental drugs; | — |
Countries
China
Contacts
Public ContactShiying Yu
Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed