Status:
COMPLETED
Olanzapine or Dexamethasone, With 5-HT3 RA and NK-1 RA, to Prevent CINV
Lead Sponsor:
Fifth Affiliated Hospital, Sun Yat-Sen University
Conditions:
Chemotherapy-induced Nausea and Vomiting
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Chemotherapy-induced nausea and vomiting is a common side effect of cancer treatments, and dexamethasone offers a clear advantage over placebo for protection against chemotherapy-induced emesis in bot...
Eligibility Criteria
Inclusion
- Inclusion Criteria (Patients are eligible to be included in the study only if they meet all of the following criteria):
- Cancer patients, age ≥ 18 years and ≤75 years, ECOG score 0-2 points, receiving cisplatin-containing doublet chemotherapy such as cisplatin + gemcitabine / albumin paclitaxel / etoposide /fluorouracil / irinotecan / temozolomide as first line treatment;
- Life expectancy ≥ 3 months;
- Leucocytes≥3,000/uL;
- AST≤2.5 × upper limit of normal;
- Bilirubin ≤1.5 × upper limit of normal;
- Serum creatinine ≤ 1.5 × upper limit of normal.
- Exclusion Criteria (Patients will be excluded if any of the following criteria is met):
- History of CNS disease, such as brain metastases or epilepsy;
- Use of other antipsychotic drugs (such as risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone, or such treatment is under scheduling during the study) within 30 days before enrollment; long-term use of phenothiazine as an antipsychotic agent;
- Concurrent use of pharyngeal or abdominal radiotherapy;
- Concurrent use of quinolone antibiotics;
- 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;
- Concurrent use of amifostine;
- Concurrent use of corticosteroids and the only anti-allergic choice is corticosteroids
Exclusion
Key Trial Info
Start Date :
February 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2022
Estimated Enrollment :
557 Patients enrolled
Trial Details
Trial ID
NCT04437017
Start Date
February 3 2020
End Date
July 1 2022
Last Update
July 29 2022
Active Locations (1)
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1
Fifth Affilliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China