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
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Xingchen Peng
- Enrollment
- 275
- Locations
- 1
- Primary Endpoint
- 0-120h Complete Remission Rate
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
Arms & Interventions
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.
Intervention: 5HT3RA+Olanzapine (Drug)
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.
Intervention: 5HT3RA+Olanzapine+Dexamethasone (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 25-120 hours Complete Remission Rate(24 hours ,48 hours, 72 hours, 96 hours, 120 hours after chemotherapy)
- 0-120h No Nausea Rate(24 hours, 48 hours, 72 hours, 96 hours, 120 hours after chemotherapy)
Investigators
Xingchen Peng
Ph.D,Professor
West China Hospital