Olanzapine and 5-HT3 With or Without Dexamethasone to Prevent CINV

Phase 3

Recruiting

• Conditions: Chemotherapy-induced Nausea and Vomiting
• Interventions: Drug: 5HT3RA+Olanzapine; Drug: 5HT3RA+Olanzapine+Dexamethasone

• Registration Number: NCT05805800
• Lead Sponsor: Xingchen Peng

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, 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-15
• Study First Submitted: 2023-03-27
• Study First Submitted QC: 2023-03-27
• Study First Posted: 2023-04-10
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-04
• Last Update Posted: 2023-11-08
• Primary Completion: 2024-03-15
• Study Completion: 2025-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 238

Inclusion Criteria

1. Patients 18 years of age or older with malignant disease；
2. Life expectancy ≥ 3 months;
3. Scheduled to receive highly emetogenic chemotherapy；
4. Had a European Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

Exclusion Criteria

1. 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);
2. History of central nervous system disease (e.g., brain metastases or a seizure disorder);
3. Severe cognitive impairment；
4. 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;
5. Concurrent use of pharyngeal or abdominal radiotherapy;
6. Concurrent use of quinolone antibiotics;
7. Concurrent use of Amifostine;
8. Chronic alcoholism;
9. Known hypersensitivity to olanzapine;
10. Know arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within 6 months;
11. Known uncontrolled diabetes mellitus;
12. Vomiting or retching 24 hours before chemotherapy;
13. Use of anti-emesis drugs 48 hours before chemotherapy;
14. Patients who require medication with dexamethasone for pretreatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5HT3RA+Olanzapine	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.
5HT3RA+Olanzapine+Dexamethasone	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.

Primary Outcome Measures

Name	Time	Method
0-120h Complete Remission Rate	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.

Secondary Outcome Measures

Name	Time	Method
25-120 hours Complete Remission Rate	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.
0-120h No Nausea Rate	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.

Trial Locations

Locations (1)

West China Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China