1. Pancreatic adenocarcinoma 2. antiemesis Pancreatic cancer mFOLFIRINOX Anti-emesis
Conditions
Interventions
NEPA 1 tab oral D1
Dexamethasone 12 mg iv D1
Dexamethasone 4 mg oral bid D2-4
,Olanzapine 5 mg oral D1
Ondansetron 8 mg iv D1
Dexamethasone 12 mg iv D1
Olanzapine 5 mg oral hs D2-4
Ondansetron 8 m
NEPA (netupitant/palonosetron),Olanzapine,Placebo
Sponsors
THE FOUNDATION FOR CANCER CARE SIRIRAJ HOSPITAL
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Pancreatic cancer patients planned for mFOLFIRINOX chemotherapy 2.No prior chemotherapy 3.ECOG Performance status 0 or 1 4.Age > 18 years 5.Patient can understand and provide voluntary written informed consent 6.Negative pregnancy test (serum or urine) done less than 7 days prior to registration, for women of childbearing potential only (per clinician discretion) 7.Adequate organ function
Exclusion criteria
Exclusion criteria: 1. Patient with current illness requiring chronic systemic steroids use or requiring chronic use of anti-emetics 2. Patients with GI obstruction who cannot take oral medication 3. Active peptic ulcer disease 4. Known Hypersensitivity to any component of the study regimen 5. Pregnant women 6. Patients using illegal drugs 7. History of pregnancy-associated emesis or motion sickness 8. Have been receiving treatment with an antipsychotic agent such as olanzapine, risperidone, quetiapine, clozapine, butyrophenone, or a phenothiazine, in the 30 days prior to registration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with CR in overall phase (CR-O) Day 1-5 Questionnaire, and visual for nausea analog scale (VAS) | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of CR in acute phase (CR-AP) during first cycle of CMT Day 1-5 Questionnaire, and visual for nausea analog scale (VAS) ,Complete response in delay phase Day 1-5 Questionnaire, and visual for nausea analog scale (VAS) ,The rate of complete protection (CP) in overall phase Day 1-5 Questionnaire, and visual for nausea analog scale (VAS) ,Proportion of patients with no nausea Day 1-5 Questionnaire, and visual for nausea analog scale (VAS) ,To determine degree of nausea rescue Day 1-5 Questionnaire, and visual for nausea analog scale (VAS) ,To determine potential toxicities related to NEPA and olanzapine Day 1-5 Questionnaire, and visual for nausea analog scale (VAS) ,To determine frequency of rescue medication Day 1-5 Questionnaire,The impact of Chemotherapy induced nausea and vomiting (CINV) on daily life Day 1-5 Questionnaire,The Quality of life Day 1-5 Questionnaire,The cost utility analysis Day 1-5 Questionnaire | — |
Countries
Thailand
Contacts
Public ContactKrittiya Korphaisarn
Faculty of Medicine Siriraj Hospital
Outcome results
None listed