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Fosapitan study on prevention of multiple-day chemotherapy with cisplatin-induced nausea and vomiting by a prospective randomized controlled trial

Fosapitan study on prevention of multiple-day chemotherapy with cisplatin-induced nausea and vomiting by a prospective randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046303
Enrollment
Unknown
Registered
2021-05-12
Start date
2021-06-01
Completion date
Unknown
Last updated
2021-12-21

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

Conditions

Malignant tumor

Interventions

Four antiemetic program group:Four antiemetic program(Day 1: Fosappitan 125mg orally once daily
Palonosetron 0.25mg once daily static push
Olanzapine 5mg orally once a day
Dexamethasone needle 5mg once a day static push
Day 2 and Day 3: Olanzapine 5mg orally once a day
Dexamethasone needle 5mg once daily static push)
Three antiemetic program group:Three antiemetic program(Day 1: palonosetron 0.25mg once daily, dexamethasone 10mg once daily, olanzapine 5mg once daily

Sponsors

Oncology Department, Ordos Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients older than 18 years who will receive 3-day cisplatin-based chemotherapy (25 mg/m2/d) enrolled in the study and had been confirmed by histology; 2. Karnofsky Performance Scale >= 70; 3. There is no abnormality in liver and kidney function, blood routine and electrocardiogram before chemotherapy, including: White blood cell count > 3.5x10^9/L, Absolute neutrophil count > 1.5x10^9/L, Platelet count > 85x10^9/L, Alkaline phosphatase< 2.5 upper limit of normal (ULN), alanine transaminase < 2.5 upper limit of normal (ULN), Bilirubin <1.5 ULN, Creatinine < 1.5 ULN; 4. Patients without chemotherapy contraindications after CT and MRI examination; 5. No episodes of nausea and vomiting during last 1 week before enrollment, and without pretreatment with aprepitant or olanzapine; 6. Informed consent and signed consent form.

Exclusion criteria

Exclusion criteria: 1. Unable to swallow pills; 2. Long-term hormone users; 3. The scheduled administration of concurrent radiotherapy; 4. Symptomatic primary or metastatic central nervous system metastasis ,have brain radiotherapy; 5. Pregnant or breast-feeding ; 6. Concurrent quinolone antibiotic therapy; 7. Partial/complete bowel obstruction; 8. Known hypersensitivity to 5-HT3 receptor, aprepitant, and olanzapine; 9. Treatment with illegal drugs or Evidence of alcohol abuse; 10. Gastrointestinal neoplasms.

Design outcomes

Primary

MeasureTime frame
overall phase complete response;

Secondary

MeasureTime frame
total phase control response;total phase protect response;FLIE scale; visual-analogue scale;

Countries

China

Contacts

Public ContactJin Gaowa

Oncology Department, Ordos Central Hospital

jingaowank@163.com+86 13327060498

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026