Chemotherapy-Induced Delayed Nausea and Vomiting
Conditions
Interventions
Dexamethasone Combined with Granisetron Transdermal Patches:Administer a piece of granisetron transdermal patch on the upper arm 24-48h before chemotherapy on Day1 and retain it for 7 days
and intravenously inject dexamethasone 10 mg 30 minutes before chemotherapy
Dexamethasone combined with NK-1 receptor antagonist and 5-HT3 receptor antagonist:Administer standard dose of 5-HT3 RA before chemotherapy on Day1
intravenous inject dexamethasone 10mg 30 minutes before chemotherapy
orally administer aprepitant capsules 125 mg 1h before chemotherapy on Day1, 80mg on Day2 and Day3 respectively
Sponsors
The Seventh Affiliated Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients included in this study must meet all of the following criteria: 1)Aged 18-75 years, male or female 2)Diagnosed malignant tumor by histopathology and/or cytology 3)Eastern Cooperative Oncology Group (ECOG) performance status =2 4)Life expectancy=3 months 5)Receiving XELOX or SOX chemotherapy regimens for the first, second or third cycle 6) Laboratory test values within screening phase meet the following criteria: Peripheral blood: hemoglobin =80g/L; granulocyte count =1.5×10^9/L; platelet count=80×10^9/L; blood biochemistry: total bilirubin <1.25× ULN (upper normal limit);ALT and AST <2.5×ULN; If the liver dysfunction is caused by liver metastasis, then the ALT and AST <5×ULN ; serum creatinine <1×ULN 7) being able to understand the protocol and are willing to participate in the study, and provide written informed consent
Exclusion criteria
Exclusion criteria: Exclusion Criteria (meet any of the following will be excluded): 1)Contraindications or severe allergic reactions to 5-HT3 receptor antagonist, NK-1 receptor antagonist or dexamethasone 2)Nausea and vomiting for any reason within 24 hours before chemotherapy starts 3)A prolonged QTcF (QTc>470msec) interval at baseline 4)Scheduled to receive whole body, brain, or upper abdominal radiation during trial process 5)Taking medication to treat brain tumors or epilepsy symptoms 6)Unable to cooperate and describe the therapeutic respond 7)A history of drug abuse and alcohol dependence 8)Pregnancy, breastfeeding or intentional pregnancy, or judged as not using sufficient contraceptive measures 9)History of severe allergic reactions to drugs with similar chemical structure or to transdermal therapeutic systems 10)Any medical history, disease evidence and abnormal values of laboratory examination that may interfere with the results of the study or hinder the subjects' full participation in the study; or other conditions that the researcher considers unsuitable for the study due to potential risks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the rate of complete response (25-120h); | — |
Secondary
| Measure | Time frame |
|---|---|
| the rate of complete response (0-24h);the rate of complete response (0-120h);the rate of complete control (25-120h);the rate of complete control (0-24h);the rate of complete control (0-120h);The rate of complete response every 24h;The rate of complete control every 24h; | — |
Countries
China
Contacts
Public ContactHua Zhang/ Benjie Zhou
The Seventh Affiliated Hospital, Sun Yat-sen University
Outcome results
None listed