A Same-Patient Comparison of Fosaprepitant and Ondansetron in the Prevention of Chemotherapy Induced Nausea and Vomiting in Head and Neck Cancer Patients

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20210122002

Enrollment

Registered

2021-01-22

Start date

2015-10-26

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 who were diagnosed as having squamous cell carcinoma of the head and neck and scheduled for treatment with induction chemotherapy by cisplatin-base regimen cisplatin fosaprepitant nausea and vomiting ondansetron squamous cell carcinoma of the head and neck

Interventions

Day 1 Ondansetron 8 mg IV infused, 30 minutes before starting chemotherapy Dexamethasone 10 mg IV infused, 30 minutes before starting chemotherapy Dexamethasone 10 mg IV infused every 4 hours after

Active Comparator Drug,Experimental Drug

standard CINV regimen,standard CINV regimen plus fosaprepitant

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients more than 18 years of age 2. were diagnosed as having squamous cell carcinoma of the head and neck 3. scheduled for treatment with induction chemotherapy by cisplatin base regimen every three weeks for two or three cycles

Exclusion criteria

Exclusion criteria: 1. had received previous chemotherapy 2. had symptoms of nausea or vomiting at presentation (disease related) 3. used chronic anti emetic therapy or daily corticosteroids prior to initiation of chemotherapy 4. were allergic to steroids 5HT3 or NK1 5. had serious or uncontrolled underlying disease 6. had medical or psychiatric illness that would interfere with ability to complete the CINV evaluation form

Design outcomes

Primary

Measure	Time frame
Complete response (Gr 0 of overall CINV grade) 0-120 hr after chemotherapy Common Terminology Criteria for Adverse Events (CTCAE) criteria (version 4.03)	—

Secondary

Measure	Time frame
severity score of CINV from patient perception 0-120 hr after chemotherapy daily CINV evaluation form	—

Contacts

Public ContactPitchayaponne Klunklin

Faculty of Medicine, Chiangmai University

pklunklin@gmail.com66846092813

Outcome results

None listed

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