This is a multicenter, randomized, controlled, double-blind, phase III study.
This is a multicenter, randomized, controlled, double-blind, phase III study assessing the efficacy and safety of Olanzapine plus fosaprepitant plus ondansetron and dexamethasone versus fosaprepitant plus ondansetron and dexamethasone in the prevention of chemotherapy-induced nausea and vomiting in patients receiving high emetic risk multi-day chemotherapy. Eligible patients will be randomized to receive either olanzapine plus fosaprepitant standard antiemetic therapy or fosaprepitant standard antiemetic therapy in a 1:1 ratio.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
352
olanzapine 5mg p.o. on day 1-day 5, fosaprepitant 150mg i.v. on day 1 before undergoing chemotherapy. Patients received ondansetron hydrochloride(8mg, i.v. day 1-day 3) and dexamethasone(6mg, oral, day 1-day 5) at the same time, before undergoing chemotherapy.
placebo p.o. on day 1-day 5, fosaprepitant 150mg i.v. on day 1 before undergoing chemotherapy. Patients received ondansetron hydrochloride(8mg, i.v. day 1-day 3) and dexamethasone(6mg, oral, day 1-day 5) at the same time, before undergoing chemotherapy.
Beijing Cancer Hospital
Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Complete response (CR) during overall phase
To compare olanzapine plus fosaprepitant regimen with placebo plus fosaprepitant regimen with respect to efficacy; complete response (CR) defined as no vomiting and no use of rescue therapy during overall phase (day 1 to day 8) after highly emetogenic chemotherapy initiation)
Time frame: Day 1 to day 8 after highly emetogenic chemotherapy initiation
Complete response (CR) during acute phase
Time frame: Day 1 to day 3 days after highly emetogenic chemotherapy initiation
Complete response (CR) during delayed phase
Time frame: Day 4 to day 8 after highly emetogenic chemotherapy initiation
No significant nausea during overall phase using questionnaire
Time frame: Day 1 to day 8 after highly emetogenic chemotherapy initiation
No significant nausea during acute phase using questionnaire
Time frame: Day 1 to day 3 after highly emetogenic chemotherapy initiation
No significant nausea during delayed phase using questionnaire
Time frame: Day 4 to day 8 after highly emetogenic chemotherapy initiation
To compare quality of life using the functional living index-emesis questionnaire
Time frame: From baseline to day 8 after highly emetogenic chemotherapy initiation
To compare olanzapine plus fosaprepitant regimen with placebo plus fosaprepitant regimen in terms of the number of days to first emetic episode.
Time frame: Day 1 to day 8 after highly emetogenic chemotherapy initiation
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Hunan Cancer Hospital
Changsha, China
Sichuan Cancer Hospital& Institute
Chengdoucun, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
Sun Yat-sen University Cancer Center
Guangdong, China
Harbin Medical University Cancer Hospital
Haerbin, China
Anhui Provincial Cancer Hospital
Hefei, China
Yunnan Cancer Hospital
Kunming, China
Jiangxi Cancer Hospital
Nanchang, China
...and 8 more locations
To compare the number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: From baseline to day 8 after highly emetogenic chemotherapy initiation
To compare the change of score using Hospital Anxiety and Depression Scale
Hospital Anxiety and Depression Scale includes two subscales: anxiety and depression, with 7 items for anxiety (a) and depression (d) respectively. Each item is divided into four grades of 0-3. The higher the score is, the more serious the anxiety and depression are.
Time frame: From baseline to day 8 after highly emetogenic chemotherapy initiation