malignant tumor
Conditions
Interventions
Research group:The patients in the study group were given Ondansetron oral film 8mg bid Huoxiang Zhengqi oral liquid 10 tid for 7 days after the end of chemotherapy.
control group:During chemotherapy, a combination of 5-HT3 receptor antagonists (5-HT3RT) neurokinin-1 (NK-1 receptor antagonists (NK-1RT) dexamethasone was given for antiemesis, and no intervention wa
Sponsors
Affiliated Hospital of Southwest Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Participants must meet the following criteria to be eligible for this clinical study: 1. Voluntarily sign a written informed consent form. 2. When signing the informed consent form, both men and women can be aged between 18 and 70 years old. 3. ECOG physical fitness score is 0 or 1. 4. Pathological diagnosis of malignant solid tumor. 5. The patient is undergoing chemotherapy for the first time and is about to receive highly emetic combination or monotherapy chemotherapy containing cisplatin (for multiple days, cisplatin is used for 3 days, the total chemotherapy time does not exceed 5 days, and the chemotherapy cycle is 21 days). 6. No history of chronic gastrointestinal diseases (such as chronic gastritis, chronic enteritis, etc.), no history of chronic nausea and vomiting (such as dizziness, Meniere's disease, etc.). 7. Good organ function: a) Hematology (no use of any blood components or cell growth factor supportive therapy within 7 days prior to initial administration): ?. Absolute neutrophil count ANC 15x10^9/L (1500/mm3); ?. Platelet count >= 100x10^9/L (100000/mm3); ?. Hemoglobin>90 g/L b) Kidney: ?. Serum creatinine 28 g/L 8. The indicators of heart function and important organ function meet the requirements of chemotherapy. 9. The subjects are willing and able to comply with the scheduled visits, treatment plans, laboratory tests, and other requirements of the study
Exclusion criteria
Exclusion criteria: 1. Patients who have not yet controlled stable cancer pain and require cancer pain titration or adjustment of opioid analgesic dosage, or whose gastrointestinal reactions to opioid drugs have not been fully controlled. 2. Long term recipients of corticosteroids. Within the past three days, there has been nausea and vomiting, regardless of the cause. 4. History of active digestive ulcers and gastrointestinal bleeding within one year. 5. Patients who cannot read, understand, or independently complete the questionnaire survey. 6. Patients with poor compliance who are expected to be unable to complete the study as planned. 7. Patients who are known to be allergic to any component of the investigational drug, unable to accept the odor of Huoxiang Zhengqi oral solution, or allergic to Huoxiang Zhengqi oral solution. Currently participating in any other clinical trials or observational studies. 9. Known history of mental illness, drug abuse, alcoholism, or drug use. 10. Pregnant or lactating women. 11. There may be any past or current diseases, treatments, or laboratory abnormalities that may confuse the research results, affect the full participation of the subjects in the study, or participation in the study may not be in the best interests of the subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate of CINV within the delay period (25 to 120 hours); | — |
Countries
China
Contacts
Public ContactZheng Yun
Affiliated Hospital of Southwest Medical University
Outcome results
None listed