Fifth Affilliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China
NCT Number: NCT04437017
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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Notify Me18 year–75 year
All sexes
Interventional
Phase 3
Zhuhai, Guangdong, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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):
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.
Other names: Acidocont, Deronil, Dexacortal, Desameton, Fluprednisolone, (11β,16α)-9-Fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione
Time frame: 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.
Time frame: 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.
Time frame: 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.
Fifth Affiliated Hospital, Sun Yat-Sen University
Other
Olanzapine or Dexamethasone, With 5-HT3 RA and NK-1 RA, to Prevent Nausea and Vomiting Induced by Cisplatin-Based Doublet Chemotherapy: A Non-inferiority, Prospective, Multi-Centered, Randomized, Controlled, Phase III Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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