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The Results of the Comparison between Olanzapine and One-Dose Dexamethasone and Four-Day Dexamethasone in Prevention of Chemotherapy induced Nausea and Vomiting in Patients with Pancreatic Cancer Receiving Modified FOLFIRINOX

The Preliminary Results of the Comparison between Olanzapine and One-Dose Dexamethasone and Four-Day Dexamethasone in Prevention of Chemotherapy induced Nausea and Vomiting in Patients with Pancreatic Cancer Receiving Modified FOLFIRINOX

Status
Unknown
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230307001
Enrollment
14
Registered
2023-03-07
Start date
2023-01-16
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with pancreatic cancer plan to receive modified FOLFIRINOX chemotherapy regimen modified FOLFIRINOX pancreatic cancer dexamethasone chemotherapy-induced nausea and vomiting Olanzapine

Interventions

antiemetic regimen with olanzapine 5 mg before chemotherapy and on day 2-4 before bedtime without dexamethasone on day 2-4. All patients received ondansetron 8 mg and dexamethasone 4 mg intravenousl
Experimental Drug,Placebo Comparator Drug
Olanzapine arm,Dexamethasone arm

Sponsors

Hathaipat Veerawatananan
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Eligible patients were 18 and 80 years old patients with Eastern Cooperative Oncology group (ECOG) performance status 0-1

Exclusion criteria

Exclusion criteria: preexisting nausea symptoms, inadequate organ function, allergy or contraindication to ondansetron, dexamethasone, olanzapine, cognitive compromise or having a history of dyskinesia, movement, CNS disorder or psychiatric disorder

Design outcomes

Primary

MeasureTime frame
complete response (CR) of vomiting (no vomiting) in the overall phase (0-120 hours) after start chemotherapy 0-120 hours after start chemotherapy rate of vomiting (no vomiting) in the overall phase

Secondary

MeasureTime frame
CR of nausea (no nausea) in the overall phase 0-120 hours after start chemotherapy rate of nausea (no nausea) ,incidence of hyperglycemia during 2 chemotherapy sessions incidence of hyperglycemia

Countries

Thailand

Contacts

Public ContactHathaipat Veerawatananan

Faculty of Medicine, Chulalongkorn University

hathaipat.vee@gmail.com6622564533

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026