Back to resultsOlanzapine and 5-HT3 With or Without Dexamethasone to Prevent CINV
Primary Purpose
Chemotherapy-induced Nausea and Vomiting
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
5HT3RA+Olanzapine
5HT3RA+Olanzapine+Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Chemotherapy-induced Nausea and Vomiting
Eligibility Criteria
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.
Sites / Locations
- West China Hospital, Sichuan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
5HT3RA+Olanzapine
5HT3RA+Olanzapine+Dexamethasone
Arm Description
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.
Outcomes
Primary Outcome Measures
0-120h Complete Remission Rate
The ratio of patients who have no vomiting and apply no anti-nausea drugs during the whole observation period.
Secondary Outcome Measures
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.
0-120h No Nausea Rate
The ratio of patients who have no nausea during the whole observation period.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05805800
Brief Title
Olanzapine and 5-HT3 With or Without Dexamethasone to Prevent CINV
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2023 (Actual)
Primary Completion Date
March 15, 2024 (Anticipated)
Study Completion Date
March 15, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xingchen Peng
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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, we 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Nausea and Vomiting
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
238 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
5HT3RA+Olanzapine
Arm Type
Experimental
Arm Description
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.
Arm Title
5HT3RA+Olanzapine+Dexamethasone
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
5HT3RA+Olanzapine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
5HT3RA+Olanzapine+Dexamethasone
Intervention Description
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
Primary Outcome Measure Information:
Title
0-120h Complete Remission Rate
Description
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
Secondary Outcome Measure Information:
Title
25-120 hours Complete Remission Rate
Description
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
Title
0-120h No Nausea Rate
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xingchen Peng, Ph.D
Phone
+8618980606753
Email
pxx2014@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25948677
Citation
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.
Results Reference
result
PubMed Identifier
28393417
Citation
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.
Results Reference
result
PubMed Identifier
24276953
Citation
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.
Results Reference
result
PubMed Identifier
19775450
Citation
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.
Results Reference
result
PubMed Identifier
27410922
Citation
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.
Results Reference
result
PubMed Identifier
28503222
Citation
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.
Results Reference
result
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Olanzapine and 5-HT3 With or Without Dexamethasone to Prevent CINV
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