Olanzapine or Dexamethasone, With 5-HT3 RA and NK-1 RA, to Prevent CINV
Keywords
Abstract
Dates
Last Verified: | 05/31/2020 |
First Submitted: | 06/15/2020 |
Estimated Enrollment Submitted: | 06/16/2020 |
First Posted: | 06/17/2020 |
Last Update Submitted: | 06/16/2020 |
Last Update Posted: | 06/17/2020 |
Actual Study Start Date: | 02/02/2020 |
Estimated Primary Completion Date: | 02/02/2022 |
Estimated Study Completion Date: | 02/02/2022 |
Condition or disease
Intervention/treatment
Drug: Olanzapine+NK-1 RA+5-HT3 RA
Drug: Dexamethasone+NK-1 RA+5-HT3 RA
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
Experimental: Olanzapine+NK-1 RA+5-HT3 RA 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. | Drug: Olanzapine+NK-1 RA+5-HT3 RA On day 1-4, Olanzapine (5mg) is delivered orally after dinner. |
Active Comparator: Dexamethasone+NK-1 RA+5-HT3 RA 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. | Drug: Dexamethasone+NK-1 RA+5-HT3 RA 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. |
Eligibility Criteria
Ages Eligible for Study | 18 Years To 18 Years |
Sexes Eligible for Study | All |
Accepts Healthy Volunteers | Yes |
Criteria | Inclusion Criteria (Patients are eligible to be included in the study only if they meet all of the following criteria): 1. Cancer patients, age ≥ 18 years and ≤75 years, ECOG score 0-2 points, receiving cisplatin-containing doublet chemotherapy such as cisplatin + gemcitabine / albumin paclitaxel / etoposide /fluorouracil / irinotecan / temozolomide as first line treatment; 2. Life expectancy ≥ 3 months; 3. Leucocytes≥3,000/uL; 4. AST≤2.5 × upper limit of normal; 5. Bilirubin ≤1.5 × upper limit of normal; 6. Serum creatinine ≤ 1.5 × upper limit of normal. Exclusion Criteria (Patients will be excluded if any of the following criteria is met): 1. History of CNS disease, such as brain metastases or epilepsy; 2. Use of other antipsychotic drugs (such as risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone, or such treatment is under scheduling during the study) within 30 days before enrollment; long-term use of phenothiazine as an antipsychotic agent; 3. Concurrent use of pharyngeal or abdominal radiotherapy; 4. Concurrent use of quinolone antibiotics; 5. Chronic alcoholism; 6. Known hypersensitivity to olanzapine; 7. Know arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within 6 months; 8. Known uncontrolled diabetes mellitus; 9. Vomiting or retching 24 hours before chemotherapy; 10. Use of anti-emesis drugs 48 hours before chemotherapy; 11. Concurrent use of amifostine; 12. Concurrent use of drugs and the only anti-allergic choice is dexamethasone |
Outcome
Primary Outcome Measures
1. Complete Remission Rate [24 hours ,48 hours, 72 hours, 96 hours, 120 hours after chemotherapy]
Secondary Outcome Measures
1. No Nausea Rate [24 hours, 48 hours, 72 hours, 96 hours, 120 hours after chemotherapy]