- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05805800
Olanzapine and 5-HT3 With or Without Dexamethasone to Prevent CINV
Olanzapine and 5-HT3 With or Without Dexamethasone to Prevent Nausea and Vomiting Induced by Chemotherapy::A Non-inferiority, Prospective, Multi-Centered, Randomized, Controlled, Phase III Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Sichuan
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Chengdu, Sichuan, China, 610041
- Recruiting
- West China Hospital, Sichuan University
-
Contact:
- Xingchen Peng, Ph.D
- Phone Number: +8618980606753
- Email: pxx2014@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients 18 years of age or older with malignant disease;
- Life expectancy ≥ 3 months;
- Scheduled to receive highly emetogenic chemotherapy;
- Had a European Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Exclusion Criteria:
- There are contraindications to chemotherapy(Absolute number of neutrophils ≤ 1,500/uL, hemoglobin ≤ 90g/L, platelet count ≤ 10000/uL, serum creatinine level ≥ 2.0mg/dl (177 μmol/L), ALT and AST ≥ 2.5 times the upper normal limit, bilirubin ≥ 1.5 times the upper normal limit);
- History of central nervous system disease (e.g., brain metastases or a seizure disorder);
- Severe cognitive impairment;
- Treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, a phenothiazine, or a butyrophenone within 30 days before enrollment or plans for such treatment during the study period;
- Concurrent use of pharyngeal or abdominal radiotherapy;
- Concurrent use of quinolone antibiotics;
- Concurrent use of Amifostine;
- Chronic alcoholism;
- Known hypersensitivity to olanzapine;
- Know arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within 6 months;
- Known uncontrolled diabetes mellitus;
- Vomiting or retching 24 hours before chemotherapy;
- Use of anti-emesis drugs 48 hours before chemotherapy;
- Patients who require medication with dexamethasone for pretreatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 5HT3RA+Olanzapine
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. |
Active Comparator: 5HT3RA+Olanzapine+Dexamethasone
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.
|
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. Other Names: Acidocont; Deronil; Dexacortal; Desameton; Fluprednisolone; (11β,16α-9-Fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
0-120h Complete Remission Rate
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.
|
24 hours ,48 hours, 72 hours, 96 hours, 120 hours after chemotherapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
0-120h No Nausea Rate
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.
|
24 hours, 48 hours, 72 hours, 96 hours, 120 hours after chemotherapy
|
25-120 hours Complete Remission Rate
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.
|
24 hours ,48 hours, 72 hours, 96 hours, 120 hours after chemotherapy
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Hu Z, Cheng Y, Zhang H, Zhou C, Han B, Zhang Y, Huang C, Chang J, Song X, Liang J, Liang H, Bai C, Yu S, Chen J, Wang J, Pan H, Chitkara DK, Hille DA, Zhang L. Aprepitant triple therapy for the prevention of chemotherapy-induced nausea and vomiting following high-dose cisplatin in Chinese patients: a randomized, double-blind, placebo-controlled phase III trial. Support Care Cancer. 2014 Apr;22(4):979-87. doi: 10.1007/s00520-013-2043-9. Epub 2013 Nov 26.
- Ng TL, Hutton B, Clemons M. Chemotherapy-Induced Nausea and Vomiting: Time for More Emphasis on Nausea? Oncologist. 2015 Jun;20(6):576-83. doi: 10.1634/theoncologist.2014-0438. Epub 2015 May 6.
- Yang LQ, Sun XC, Qin SK, Cheng Y, Shi JH, Chen ZD, Wang QM, Zhang HL, Hu B, Liu B, Zhang QY, Wu Q, Wang D, Shu YQ, Dong J, Han BH, Wang KM, Dang CX, Li JL, Wang HB, Li BL, Lu JG, Zhang ZH, Chen YX. Efficacy and safety of fosaprepitant in the prevention of nausea and vomiting following highly emetogenic chemotherapy in Chinese people: A randomized, double-blind, phase III study. Eur J Cancer Care (Engl). 2017 Nov;26(6):e12668. doi: 10.1111/ecc.12668. Epub 2017 Apr 10.
- Tan L, Liu J, Liu X, Chen J, Yan Z, Yang H, Zhang D. Clinical research of Olanzapine for prevention of chemotherapy-induced nausea and vomiting. J Exp Clin Cancer Res. 2009 Sep 23;28(1):131. doi: 10.1186/1756-9966-28-131.
- Navari RM, Qin R, Ruddy KJ, Liu H, Powell SF, Bajaj M, Dietrich L, Biggs D, Lafky JM, Loprinzi CL. Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting. N Engl J Med. 2016 Jul 14;375(2):134-42. doi: 10.1056/NEJMoa1515725.
- Chelkeba L, Gidey K, Mamo A, Yohannes B, Matso T, Melaku T. Olanzapine for chemotherapy-induced nausea and vomiting: systematic review and meta-analysis. Pharm Pract (Granada). 2017 Jan-Mar;15(1):877. doi: 10.18549/PharmPract.2017.01.877. Epub 2017 Mar 15.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Signs and Symptoms, Digestive
- Nausea
- Vomiting
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Serotonin Receptor Agonists
- Selective Serotonin Reuptake Inhibitors
- Dexamethasone
- Olanzapine
- Serotonin
Other Study ID Numbers
- 2023-157
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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