Chemotherapy-induced nausea and vomiting
Conditions
Interventions
Research group:Intravenous injection
Sponsors
The Affiliated Hospital of Jiangsu University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Adult patients aged 18-75 years; 2. Diagnosed as malignant tumor, highly emetogenic anti-tumor chemotherapy (such as AC\ platinum, see Appendix 3 for details) should be used for chemotherapy; Multi-day chemotherapy subgroup: chemotherapy regimen >=3 days; 3. No history of chronic gastrointestinal diseases causing recurrent nausea and vomiting, no history of chronic nausea and vomiting (such as vertigo, Meniere syndrome); 4. Survival is expected to be greater than 3 months; 5. The patient and the patient's spouse are willing to take effective contraceptive measures; 6. Patients voluntarily participate in the study and are capable of following planned study visits, treatment protocols, and other study steps;
Exclusion criteria
Exclusion criteria: 1. Currently receiving treatment in other therapeutic clinical studies; 2. Subjects who have not yet controlled stable cancer pain, need to titrate cancer pain or adjust the dose of opioid painkillers, or have digestive reactions to opioids that have not been fully controlled; 3. Nausea and vomiting of any kind have occurred within 3 days before screening; 4. Subjects who cannot read or complete the questionnaire independently; 5. Use of pimoxide, warfarin, moderate to strong CYP3A4 inhibitors (such as diltiazem, ketoconazole, itraconazole, etc.) or strong CYP3A4 inducers (such as rifampicin, carbamazepine, phenytoin, etc.) in the 2 weeks prior to screening; 6. Antiemetic drugs with the same mechanism as the drugs in this study were administered within 24 hours before chemotherapy, except for drugs with the purpose of chemotherapy pretreatment; 7. Patients who are known to be allergic to the investigational drug or its ingredients; 8. Situations that other researchers consider inadmissible;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of complete remission, defined as the time between the start of chemotherapy and the first vomiting (including retching) or the use of remedial treatment (used to treat nausea or vomiting); | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients achieving nausea control on day 1 after chemotherapy, on days 2 to 5, and on days 6 to 14.;Frequency and severity of vomiting per day.;The number of rescue treatments and the time of the first rescue treatment on day 1 after chemotherapy, on days 2 to 5, and on days 6 to 14.;The incidence of chemotherapy-induced nausea and vomiting within 120 hours after the completion of the next chemotherapy cycle (all using the single-dose Aprepitant injection regimen).;The proportion of patients achieving complete remission on day 1 after chemotherapy, on days 2 to 5, and on days 6 to 14.;The duration of complete control or nausea control.;A separate subgroup analysis was conducted for patients who received chemotherapy for multiple days (>=3 days),The indicators are consistent with the above.;The proportion of patients achieving complete control (complete control, CC) on day 1 after chemotherapy, on days 2 to 5, and on days 6 to 14.; | — |
Countries
China
Contacts
Public ContactDai Chunhua
The Affiliated Hospital of Jiangsu University
Outcome results
None listed