chemotherapy-induced nausea and vomiting
Conditions
Interventions
A group:Administer an intravenous injection of 5 mg dexamethasone 0.5 hours before each chemotherapy cycle, and orally take one Netupitant-Palonosetron capsule (containing 0.3 g netupitant and 0.5 mg
C group:Take one Netupitant Palonosetron capsule (each containing 0.3g netupitant and 0.5mg palonosetron hydrochloride) orally 1 hour before each chemotherapy cycle and again at 48 hours after the che
B group:Take 1 Netupitant and Palonosetron capsule orally 1 hour before each chemotherapy cycle (each capsule contains 0.3 g netupitant and 0.5 mg palonosetron hydrochloride), and take Olanzapine tabl
Sponsors
Zhongshan Hospital Affiliated to Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 75 years; 2.Diagnosed with a malignant tumor and scheduled to receive a moderately to highly emetogenic chemotherapy regimen; 3.Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 4.Has an estimated life expectancy of =12 weeks at screening and is eligible to receive at least one more cycle of the current antitumor regimen; 5.Female patients of childbearing potential agree to use contraception during the study and for 6 months after study completion must not be lactating. Male patients agree to use contraception during the study and for 6 months after study completion; 6.Voluntarily participates in the study, signs the informed consent form, and is expected to have good compliance.
Exclusion criteria
Exclusion criteria: 1.Having received radiotherapy within 1 week prior to chemotherapy; 2.Suffering from other conditions that may cause nausea or vomiting unrelated to chemotherapeutic drugs, including but not limited to gastrointestinal obstruction or central nervous system malignancies; 3.Presence of vomiting, nausea, or retching symptoms within 24 hours before treatment initiation; 4.Concurrent use of corticosteroids or any other potential antiemetic medications; 5.Contraindications to corticosteroids; 6.Presence of cognitive impairment (e.g., dementia or severe learning difficulties) that would prevent completion of nausea and vomiting assessment scales; 7.Use of antipsychotic drugs within 30 days prior to the start of treatment or during the treatment period; 8.Severe uncontrolled disease affecting the hepatic, renal, cardiovascular, respiratory, endocrine systems, or central nervous system; 9.Known allergy to the study drug(s); 10.Pregnant or lactating women; 11.Participation in any other clinical trial involving an investigational drug or device within 3 months prior to screening; 12.Any other condition considered by the investigator to pose a significant risk to the subject's health or safety, or that may affect the efficacy evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The complete response rate throughout the entire observation period of the first cycle (0-168 hours);The proportion of subjects with complete control in the acute phase, delayed phase, long delayed phase and overall phase of the first cycle and the second cycle (CCR).; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects who achieved complete remission in the acute phase (0-24 hours), delayed phase (> 24-120 hours), and long delayed phase (120-168 hours) of the second cycle;The changes in the quality of life (QoL) score of patients before and after each treatment cycle, including the Vomiting Life Function Scale (FLIE);The proportion of subjects who achieved complete remission in the acute phase (0-24 hours), delayed phase (> 24-120 hours), and long delayed phase (120-168 hours) of the first cycle;;The complete response rate throughout the entire observation period of the second cycle (0-168 hours);The occurrence time of treatment failure in each cycle;The proportion of subjects with overall control in the first cycle, the acute phase, the delayed phase, the long delayed phase, and the overall phase of the second cycle (TCR).; | — |
Countries
China
Contacts
Public ContactLi Xiao
Zhongshan Hospital Affiliated to Xiamen University
Outcome results
None listed