chemotherapy-induced nausea and vomiting. Nausea and vomiting
Conditions
Interventions
Intervention 1: Intervention group: Eligible patients will receive: Triple Standard of Care Regimen [Aprepitant Capsule (125 mg PO on day 1, 80 mg on days 2-3), Ondansetron (8 mg IV only on day 1) or
Sponsors
Mazandaran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Cisplatin=50 mg/m² or doxorubicin =50 mg/m² plus cyclophosphamide =500 mg/m² regimen recipient Not receiving chemotherapy in the past People over 18 years old Having normal bone marrow function (ANC>1500/mm3 and Plt>100000//mm3) Eastern Cooperative Oncology Group performance status(ECOG) 0-2 Without known cardiac arrhythmia Having normal liver function (bili<1.5 mg/dl and liver enzymes level less than three times the maximum normal range) and normal kidney function (EGFR =30 ml/min/1.73m2)
Exclusion criteria
Exclusion criteria: History of allergy to mirtazapine and olanzapine History of MI, cardiac arrhythmia and CHF History of known psychiatric disorders Uncontrolled diabetes Consumption of drugs that interact with the study drugs like CYP3A4 inducers and other antidepressant or antipsychotics Pregnant or lactating women Lack of consent to participate in the study Brain metastasis or metastases associated with gastrointestinal obstruction History of known GI bleeding Use of systemic steroids or other anti-nausea and vomiting drugs outside the study protocol Ischemic or hemorrhagic stroke Taking antiepileptic drugs Use of drugs like dexamethasone, 5HT3 antagonist, antihistamine and muscarinic, dopamine receptor antagonist and NK1 receptor antagonist and benzodiazepine during 48 hours before starting the study Nausea and vomiting during 24 hours before starting the study Use of opioids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of Nausea. Timepoint: During the Acute Phase [0-24 hours after chemotherapy], the Delayed (24-120 hours after chemotherapy) and the overall (0-120 hours after chemotherapy) phases for two chemotherapy cycles. Method of measurement: National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.;Severity of Vomiting. Timepoint: During the Acute Phase [0-24 hours after chemotherapy], the Delayed (24-120 hours after chemotherapy) and the overall (0-120 hours after chemotherapy) phases for two chemotherapy cycles. Method of measurement: National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of The Quality of Life in Two Groups receiving Mirtazapine and Olanzapine. Timepoint: 120 Hours after Initiation of each cycle of Chemotherapy. Method of measurement: 18-item Functional Living Index-Emesis (FLIE) Questionnaire.;Severity of adverse Events. Timepoint: 120 Hours after Chemotherapy. Method of measurement: National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactEbrahim salehifar
Mazandaran University of Medical Sciences
Outcome results
None listed