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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
557
On day 1-4, Olanzapine (5mg) is delivered orally after dinner.
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.
Fifth Affilliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China
0-120h Complete Remission Rate
The ratio of patients who have no vomiting and apply no anti-nausea drugs during the whole observation period.
Time frame: 24 hours ,48 hours, 72 hours, 96 hours, 120 hours after chemotherapy
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.
Time frame: 24 hours , 48 hours, 72 hours, 96 hours, 120 hours after chemotherapy
0-120h No Nausea Rate
The ratio of patients who have no nausea during the whole observation period.
Time frame: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours after chemotherapy
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