Clinical Trial: Aprepitant ,Olanzapine,Palonosetron and Dexamethasone for the Prevention of Chemotherapy-induced Nausea and Vomiting
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Aprepitant ,Olanzapine,Palonosetron and Dexamethasone for the Prevention of Chemotherapy-induced Nausea and Vomiting---A Randomized Single Center Phase III Trial
Brief Summary: 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.
Detailed Summary: 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.
Sponsor: First Affiliated Hospital of Harbin Medical University
Current Primary Outcome:
- Proportion of Participants Receiving HEC With Complete Response in Overall Phase [ 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.
- Proportion of Participants Receiving MEC With Complete Response in Overall Phase [ 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.
Original Primary Outcome:
- Complete Response [ Time Frame: 0 to 120 hours post chemotherapy ]The primary endpoint is the rate of patients achieving a complete response(defined as no emetic episode and no use of rescue medication) during over all time (0 to 120 hours post chemotherapy)
- Safety and tolerability as measured by by the incidence and severity of adverse events [ Time Frame: 0 to 120 hours post chemotherapy ]To evaluate the safety and tolerability by the incidence and severity of adverse events during the treatment (0 to 120 hours post chemotherapy)
Current Secondary Outcome:
- Proportion of Participants Receiving HEC With Complete Response in the Acute Phase [ 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.
- Proportion of Participants Receiving HEC With Complete Response in the Delayed Phase [ 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.
- Proportion of Participants Receiving HEC With No Vomiting in the Overall Phase [ 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).
- Proportion of Participants Receiving HEC With No Vomiting in the Acute Phase [ 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 ）
- Proportion of Participants Receiving HEC With No Vomiting in the Delayed Phase [ 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).
- Proportion of Participants Receiving MEC With Complete Response in the Acute Phase [ 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.
- Proportion of Participants Receiving MEC With Complete Response in the Delayed Phase [ 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.
- Proportion of Participants Receiving MEC With No Vomiting in the Overall Phase [ 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).
- Proportion of Participants Receiving MEC With No Vomiting in the Acute Phase [ 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).
- Proportion of Participants Receiving MEC With No Vomiting in the Delayed Phase [ 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).
Original Secondary Outcome:
- Acute Phase Response [ Time Frame: 0 to 24 hours post chemotherapy ]To determine the effect on complete response(defined as no emetic episode and no use of rescue medication) rates in the acute (0 to 24 hours) phase of CINV.
- Delayed Phase Response [ Time Frame: >24 to 120 hours post chemotherapy ]To determine the effect on complete response (defined as no emetic episode and no use of rescue medication)rates in the delayed (>24 to 120 hours post chemotherapy) phase of CINV.
- Quality of life [ Time Frame: 6 days ]quality of life should be recorded 24 hours before chemotherapy for the first time ,and be recorded again after treatment, it is better to record quality of life within 2 days after treatment.
Information By: First Affiliated Hospital of Harbin Medical University
Dates:
Date Received: June 22, 2015
Date Started: May 2015
Date Completion:
Last Updated: February 13, 2017
Last Verified: June 2016
