Department of Medical Oncology
Jinan, Shandong, China
NCT Number: NCT07403370
Olanzapine is an effective antiemetic agent for preventing highly emetogenic regimens-induced nausea and vomiting (HER-INV) in patients receiving highly emetogenic regimens (HER). The optimal dose remains debated, with the standard 10 mg dose often causing significant daytime sedation. Recent evidence suggests that lower doses (2.5 mg and 5 mg) may offer comparable efficacy with improved tolerability. However, no head-to-head randomized controlled trials (RCTs) directly compare all three doses.
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Observational
Jinan, Shandong, China
To compare the relative efficacy and safety of olanzapine at 2.5 mg, 5 mg, and 10 mg, in combination with standard triple antiemetic prophylaxis, for the prevention of HER-INV in adult patients undergoing HER, using a network meta-analysis (NMA) of RCTs. RCTs comparing any two doses of olanzapine (2.5 mg, 5 mg, 10 mg) in adults with solid tumors.
Inclusion criteria
Exclusion criteria
Information Sources: Electronic databases: PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science Core Collection. We will also search clinical trial registries (ClinicalTrials.gov, WHO ICTRP) and manually review reference lists of relevant systematic reviews and included studies.
Risk of Bias Assessment: The risk of bias for individual RCTs will be assessed using the revised Cochrane Risk of Bias tool for randomized trials (RoB 2.0) by two independent reviewers.
Subgroup Analyses: Subgroup analyses are planned by treatment regimens (such as: cisplatin-based vs. AC-based et al.).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Olanzapine (dose: 2.5 mg) vs. olanzapine (dose: 5 mg) vs. olanzapine (dose: 10 mg)
Time frame: Nausea and vomiting complete response was assesed during the treatment period (or during the overall assessment period) after the initiation of highly emetogenic regimens, up to 4 weeks.
Nausea and vomiting complete response (CR; no vomiting or retching, no rescue medication) rate in the overall phase (including acuted [0-24h] and delayed [>24h] phase ) after highly emetogenic regimens in solid tummors .
Shandong Cancer Hospital and Institute
Other
Olanzapine 2.5 mg Versus 5 mg Versus 10 mg in Highly Emetogenic Regimens: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials.
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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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