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Chemotherapy-induced nausea and vomiting is a common side effect of cancer treatments, and dexamethasone offers a clear advantage over placebo for protection against chemotherapy-induced emesis in both acute and delayed phases. However, its side effects such as moderate to severe insomnia, hyperglycemia, dyspepsia, upper abdominal discomfort, irritability, increased appetite, weight gain and acne are gathering increasing concerns. Several clinical trials have shown that olanzapine plays an important role in treating delayed, refractory, breakthrough nausea and vomiting. Its side effects mainly include sedation and weight gaining. At present, the NCCN guidelines have recommended olanzapine-containing three-drug regimen for Highly Emetogenic Chemotherapy (HEC) and moderate emetic chemotherapy (MEC) to prevent vomiting, but its data in the Chinese population is limited. Hence, we initiated this prospective, multi-center, phase III study to validate the dexamethasone-free protocol: applying olanzapine to prevent CINV instead of dexamethasone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olanzapine+NK-1 RA+5-HT3 RA | Experimental | Using one of the 5-HT3 receptor antagonists (a. Palonosetron: 0.25 mg d1 intravenous; b. Granisetron: 1 mg d1 intravenously, or 2 mg d1 orally; c. Ondansetron: 8-16 mg d1 intravenous or oral. the specific agent is chosen by the primary clinician, and is only delivered on the first day) within 30 minutes before cisplatin. Using one of the NK-1 receptor antagonists(a. Aprepitant: 125 mg orally, d1, 80 mg orally, d2-3; b. Fosaprepitant: 150 mg intravenously, d1) within 1 hour before cisplatin. On day 1-4, Olanzapine (5mg) is delivered orally after dinner. |
|
| Dexamethasone+NK-1 RA+5-HT3 RA | Active Comparator | Using one of the 5-HT3 receptor antagonists (a. Palonosetron: 0.25 mg d1 intravenous; b. Granisetron: 1 mg d1 intravenously, or 2 mg d1 orally; c. Ondansetron: 8-16 mg d1 intravenous or oral. the specific agent is chosen by the primary clinician, and is only delivered on the first day) within 30 minutes before cisplatin. Using one of the NK-1 receptor antagonists (a. Aprepitant: 125 mg orally, d1, 80 mg orally, d2-3; b. Fosaprepitant: 150 mg intravenously, d1) within 1 hour before cisplatin. On first day, dexamethasone (12 mg) is given orally/intravenously within 30 minutes before cisplatin administered, and on day 2-4, the given dose of dexamethasone is 8 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olanzapine+NK-1 RA+5-HT3 RA | Drug | On day 1-4, Olanzapine (5mg) is delivered orally after dinner. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 0-120h Complete Remission Rate | The ratio of patients who have no vomiting and apply no anti-nausea drugs during the whole observation period. | 24 hours ,48 hours, 72 hours, 96 hours, 120 hours after chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| 25-120 hours Complete Remission Rate | The ratio of patients who have no vomiting and apply no anti-nausea drugs during the 25-120 hours observation period. | 24 hours , 48 hours, 72 hours, 96 hours, 120 hours after chemotherapy |
| 0-120h No Nausea Rate |
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Inclusion Criteria (Patients are eligible to be included in the study only if they meet all of the following criteria):
Exclusion Criteria (Patients will be excluded if any of the following criteria is met):
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| Name | Affiliation | Role |
|---|---|---|
| Zhigang Liu, M.D. | Fifth Affilliated Hospital of Sun Yat-sen University | Study Director |
| Zhigang Liu, M.D. | Fifth Affilliated Hospital of Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fifth Affilliated Hospital of Sun Yat-sen University | Zhuhai | Guangdong | China |
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| ID | Term |
|---|---|
| D014839 | Vomiting |
| D009325 | Nausea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002123 | Calcium Dobesilate |
| D005477 | Fluprednisolone |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Dexamethasone+NK-1 RA+5-HT3 RA | Drug | On first day, dexamethasone (12 mg) is given orally/intravenously within 30 minutes before cisplatin administrated, and on day 2-4, the given dose of dexamethasone is 8 mg. |
|
|
The ratio of patients who have no nausea during the whole observation period.
| 24 hours, 48 hours, 72 hours, 96 hours, 120 hours after chemotherapy |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |