Equivalency study of novel current standard 3-drugs combination regimen (ondansetron, dexamethasone and olanzapine) to netupitant containing regimen for preventing high dose cisplatin induce nausea and vomiting treatment, double blind placebo control trial

Equivalency study of novel current standard 3-drugs combination regimen (ondansetron, dexamethasone and olanzapine) to netupitant containing regimen for preventing high dose cisplatin induce nausea and vomiting treatment, double blind placebo control

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20190508001

Enrollment

100

Registered

2019-05-08

Start date

2019-04-01

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

Patient with cancer who will receive high dose cisplatin chemotherapy. Age â‰¥ 18 years old no previously treat with chemotherapy NK1 receptor antagonist Serotonin receptor antagonist Netupitant Palonosetron High emetic chemotherapy(HEC)

Interventions

Netupitant containing regimen (NEPA&#44

dexamethasone&#44

and olanzapine) is a standard of care for preventing highly emetogenic chemotherapy induce nausea and vomiting.,novel current standard 3&#45

drugs combination regimen (ondansetron&#44

and olanzapine

Experimental Drug,Active Comparator Drug

Netupitant containing regimen,Novel current standard regimen

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Be â‰¥18 years of age on day of signing informed consent. ECOG performance status of 0 or 1 Has histologically or cytologically confirmed diagnosis of cancer - Have received no prior systemic chemotherapy - Subjects scheduled to receive at least 2 consecutive cycles of a high dose cisplatin regimen (cisplatin > 75 mg/m2) - Demonstrates adequate organ function - CrCl > 30mL/min - SGOT or SGPT 1500/mm3 - Provide written informed consent/assent for the trial

Exclusion criteria

Exclusion criteria: - Any vomiting or nausea within 24 hours prior to the start of cisplatin chemotherapy - Is pregnant or breastfeeding - Psychiatric disorder or severe amnesia - Symptomatic primary or metastatic central nervous system (CNS) malignancy. - Has current use other antipsychotic, eg. risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone within 30 days prior to the start of cisplatin chemotherapy - Severe or uncontrolled cardiovascular diseases, eg. Cardiac arrhythmia, heart failure or myocardial infraction - Difficult control diabetic mellitus or has history of hyperglycemic emergency - Has active upper gastrointestinal cancer

Design outcomes

Primary

Measure	Time frame
complete response 0-120 hours after chemotherapy treatment no vomiting and no rescue medication use	—

Secondary

Measure	Time frame
Quality of life evaluate before and after chemotherapy treatment EORTC QLQ C-30,QTc prologation evaluate before and after chemotherapy treatment EKG 12 leads	—

Countries

Thailand

Contacts

Public ContactChanida Vinayanuwattikun

Medical oncology department, faculty of medicine, Chulalongkorn university

nutechu@gmail.com

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026

Equivalency study of novel current standard 3&#45;drugs combination regimen (ondansetron&#44; dexamethasone and olanzapine) to netupitant containing regimen for preventing high dose cisplatin induce nausea and vomiting treatment&#44; double blind placebo control trial