Nausea and vomiting caused by chemotherapy are considered by patients as the main side effects of cancer treatment, which affect the quality of treatment and life.At present, NCCN guidelines have recommended three or four drug regimens for highly emetic chemotherapy (HEC) to prevent vomiting, all containing dexamethasone.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.For certain patients, the use of dexamethasone should be avoided.Analysis shows that olanzapine can replace the effect of dexamethasone.Hence, the investigators initiated this prospective, multi-center, phase III study to validate the dexamethasone-free protocol: removing dexamethasone from a three drug regimen containing olanzapine, dexamethasone, and 5-HT3RA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
275
Using one of the 5-HT3 receptor antagonists within 30 minutes before cisplatin/adriamycin/cyclophosphamide. On day 1-4, Olanzapine is delivered orally after dinner.
Using one of the 5-HT3 receptor antagonists within 30 minutes before cisplatin/adriamycin/cyclophosphamide. On day 1-4, Olanzapine is delivered orally after dinner. On first day, dexamethasone is given orally within 30 minutes before cisplatin/adriamycin/cyclophosphamide administered.
West China Hospital, Sichuan University
Chengdu, Sichuan, 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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