First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000, China
NCT Number: NCT02484911
The purpose of the study is to mainly evaluate the efficacy and safety of aprepitant in combination with olanzapine ,palonosetron and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly or moderately emetogenic chemotherapy.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Harbin, Heilongjiang, 150000, China
Eligible patients will be randomized to receive different antiemetic regimens . In the experimental group,patients will receive aprepitant,olanzapine ,palonosetron and dexamethasone .In the other group,patients will accept the same dose of aprepitant ,palonosetron and dexamethasone .During the treatment, any grade of nausea and vomiting should be recorded in order to evaluate the complete response rate of CINV,nausea patients will be measured by a visual analogue scale (VAS) ,other adverse events should be recorded as well.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
5mg,twice a day orally on day 1 to day 4
125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3.
0.25mg IV 30-60min before chemotherapy on day 1
6mg IV on day 1 ,3.75mg IV on day 2 to 4
Time frame: 0 to 120 hours
Overall phase was defined as 0 to 120 hours following initiation of chemotherapy.
Complete response was defined as no vomiting with no rescue therapy.
Time frame: 0 to 120 hours
Overall phase was defined as 0 to 120 hours following initiation of chemotherapy.
Complete response was defined as no vomiting with no rescue therapy.
Time frame: 0 to 24 hours
Acute phase was defined as 0 to 24 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.
Time frame: 24 to 120 hours
Delayed phase was defined as 24 to 120 hours following initiation of chemotherapy.
Complete response was defined as no vomiting with no rescue therapy.
Time frame: 0 to 120 hours
Overall phase was defined as 0 to 120 hours following initiation of chemotherapy.
No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy).
Time frame: 0 to 24 hours
Overall Phase was defined as 0 to 120 hours following initiation of chemotherapy.
No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue )
Time frame: 24 to 120 hours
Overall Phase was defined as 24 to 120 hours following initiation of chemotherapy.
No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy).
Time frame: 0 to 24 hours
Acute phase was defined as 0 to 24 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.
Time frame: 24 to 120 hours
Delayed phase was defined as 24 to 120 hours following initiation of chemotherapy.
Complete response was defined as no vomiting with no rescue therapy.
Time frame: 0-120 hours
Overall Phase was defined as 0 to 120 hours following initiation of chemotherapy.
No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy).
Time frame: 0 to 24 hours
Overall Phase was defined as 0 to 24 hours following initiation of chemotherapy.
No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy).
Time frame: 24 to 120 hours
Overall Phase was defined as 24 to 120 hours following initiation of chemotherapy.
No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy).
First Affiliated Hospital of Harbin Medical University
Other
Aprepitant ,Olanzapine,Palonosetron and Dexamethasone for the Prevention of Chemotherapy-induced Nausea and Vomiting---A Randomized Single Center Phase III Trial
Acronym: AOPDPCINV
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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