Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Jiangsu Hansoh Pharmaceutical Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| olanzapine plus fosaprepitant-based triple regimen | Experimental | Olanzapine(5mg p.o. d1-d5)plus fosaprepitant(150mg i.v. d1-d3) plus ondansetron(8mg i.v. d1-d3)and dexamethasone(6mg p.o. d1-d5) before undergoing chemotherapy. |
|
| Placebo plus fosaprepitant-based triple regimen | Placebo Comparator | Placebo plus fosaprepitant(150mg i.v. d1-d3) plus ondansetron(8mg i.v. d1-d3)and dexamethasone(6mg p.o. d1-d5) before undergoing chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| olanzapine plus fosaprepitant-based triple regimen | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Day 1 to day 8 after highly emetogenic chemotherapy initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response (CR) during acute phase | Day 1 to day 3 days after highly emetogenic chemotherapy initiation | |
| Complete response (CR) during delayed phase | Day 4 to day 8 after highly emetogenic chemotherapy initiation |
| Measure | Description | Time Frame |
|---|---|---|
| The plasma concentration of 5-hydroxytryptamine and substance P at the baseline | To explore the relationship between plasma concentration of 5-hydroxytryptamine、substance P and efficacy | From baseline to day 8 after highly emetogenic chemotherapy initiation |
Inclusion Criteria: (abbreviated)
Exclusion Criteria: (abbreviated)
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Zhang | Contact | +86 20-87342288 | zhangli@sysucc.org.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36712888 | Derived | Zhao Y, Yang Y, Gao F, Hu C, Zhong D, Lu M, Yuan Z, Zhao J, Miao J, Li Y, Zhu J, Wang C, Han J, Zhao Y, Huang Y, Zhang L. A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial of olanzapine plus triple antiemetic regimen for the prevention of multiday highly emetogenic chemotherapy-induced nausea and vomiting (OFFER study). EClinicalMedicine. 2022 Dec 15;55:101771. doi: 10.1016/j.eclinm.2022.101771. eCollection 2023 Jan. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| placebo plus fosaprepitant-based triple regimen | Drug | 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. |
|
| No significant nausea during overall phase using questionnaire | Day 1 to day 8 after highly emetogenic chemotherapy initiation |
| No significant nausea during acute phase using questionnaire | Day 1 to day 3 after highly emetogenic chemotherapy initiation |
| No significant nausea during delayed phase using questionnaire | Day 4 to day 8 after highly emetogenic chemotherapy initiation |
| To compare quality of life using the functional living index-emesis questionnaire | 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. | Day 1 to day 8 after highly emetogenic chemotherapy initiation |
| To compare the number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 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. | From baseline to day 8 after highly emetogenic chemotherapy initiation |
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | China |
|
| 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 |
|
| Guangxi Medical University Affiliated Tumor Hospital | Nanning | China |
|
| Ningbo Medical Center Lihuili Hospital | Ningbo | China |
| Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University | Shanghai | China |
|
| Liaoning Cancer Hospital & Institute | Shenyang | China |
|
| Fourth Hospital of Hebei Medical University | Shijiazhuang | China |
|
| The First Affiliated Hospital of Soochow University | Suzhou | China |
|
| Tianjin Medical University General Hospital | Tianjin | China |
|
| Henan Cancer Hospital | Zhengzhou | China |
|
| ID | Term |
|---|---|
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided