Olanzapine or Dexamethasone, With 5-HT3 RA and NK-1 RA, to Prevent CINV
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Interventions
- Drug: Olanzapine+NK-1 RA+5-HT3 RADrug: Dexamethasone+NK-1 RA+5-HT3 RA
- Registration Number
- NCT04437017
- Lead Sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 557
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Olanzapine+NK-1 RA+5-HT3 RA 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. Dexamethasone+NK-1 RA+5-HT3 RA 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.
- Primary Outcome Measures
Name Time Method 0-120h Complete Remission Rate 24 hours ,48 hours, 72 hours, 96 hours, 120 hours after chemotherapy The ratio of patients who have no vomiting and apply no anti-nausea drugs during the whole observation period.
- Secondary Outcome Measures
Name Time Method 0-120h No Nausea Rate 24 hours, 48 hours, 72 hours, 96 hours, 120 hours after chemotherapy The ratio of patients who have no nausea during the whole observation period.
25-120 hours Complete Remission Rate 24 hours , 48 hours, 72 hours, 96 hours, 120 hours after chemotherapy The ratio of patients who have no vomiting and apply no anti-nausea drugs during the 25-120 hours observation period.
Trial Locations
- Locations (1)
Fifth Affilliated Hospital of Sun Yat-sen University
🇨🇳Zhuhai, Guangdong, China