Using Olanzapine to Prevent Nausea and Vomiting from Chemotherapy

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

This study is testing if olanzapine can help prevent nausea and vomiting from chemotherapy without using dexamethasone in patients receiving strong chemotherapy treatments.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 238 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: West China Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT05805800 on ClinicalTrials.gov

What this trial studies

This phase III clinical trial aims to evaluate the effectiveness of a treatment regimen that includes olanzapine and a 5-HT3 receptor antagonist, with and without the addition of dexamethasone, to prevent chemotherapy-induced nausea and vomiting (CINV). The study focuses on patients undergoing highly emetogenic chemotherapy and seeks to validate a protocol that eliminates dexamethasone, which is associated with various side effects. By comparing the two treatment approaches, the trial aims to determine if olanzapine can effectively replace dexamethasone in managing CINV. The study is being conducted at multiple centers, including West China Hospital, Sichuan University.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with malignant diseases who are scheduled to receive highly emetogenic chemotherapy.

Not a fit: Patients with contraindications to chemotherapy or those with severe cognitive impairment or central nervous system diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer alternative for preventing nausea and vomiting in chemotherapy patients, reducing the side effects associated with dexamethasone.

How similar studies have performed: Other studies have explored the use of olanzapine for CINV, suggesting potential success in similar approaches, but this specific protocol is novel.

Eligibility criteria

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.

Where this trial is running

Chengdu, Sichuan

• West China Hospital, Sichuan University — Chengdu, Sichuan, China (RECRUITING)

Conditions: Chemotherapy-induced Nausea and Vomiting