Status:
COMPLETED
Anti-emetic Prophylaxis With or Without Dexamethasone
Lead Sponsor:
Henan Cancer Hospital
Conditions:
Chemotherapy-induced Nausea and Vomiting
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
Brief Summary
To evaluate the efficacy and safety of a fosaprepitant, tropisetron, and olanzapine antiemetic regimen, with or without dexamethasone, in patients receiving highly emetogenic chemotherapy with epirubi...
Detailed Description
Patients in this study were randomly assigned in a 1:1 ratio to one of two groups using an interactive response system with permuted blocks of four, stratified by age (\<55 vs. ≥55 years). They receiv...
Eligibility Criteria
Inclusion
- Breast cancer patients receiving their first anthracycline/cyclophosphamide-based HEC regimen (cyclophosphamide 600 mg/m², epirubicin 90-100 mg/m²); divided doses excluded.
- No prior chemotherapy.
- Aged 18-70 years.
- ECOG performance status 0 or 1.
- Adequate organ function: (including absolute neutrophil count≥1,500/mm3, WBC count≥3,000/mm3, platelet count≥100,000/mm3, AST\< 2.5×the upper limit of normal (ULN), ALT\< 2.5×ULN, bilirubin\< 1.5×ULN, creatinine\< 1.5×ULN).
- No nausea or vomiting within 24 hours before registration.
- Negative pregnancy test within 7 days prior (women of childbearing potential).
- No severe cognitive impairment.
- No hypersensitivity to fosaprepitant, tropisetron, olanzapine, and dexamethasone.
- No significant cardiac issues: arrhythmia, recent heart failure, or myocardial infarction within 6 months.
- No symptomatic brain metastasis or carcinomatous meningitis.
- No diabetes requiring insulin or oral medication.
- No use of prohibited medications within 48 hours before registration or during treatment.
- Informed consent obtained.
Exclusion
- History of allergic reactions to study drugs or their analogues.
- Nausea and vomiting requiring antiemetic treatment at registration.
- Pregnant or nursing women, those who may become pregnant, or those not planning to use contraception.
- Mental illness or psychiatric symptoms interfering with daily activities, making study participation difficult.
- Diabetes treated with insulin/oral hypoglycemics or HbA1c (NGSP) ≥ 6.5% or HbA1c (JDS) ≥ 6.1% at registration.
- Recent (within 6 months) unstable angina, myocardial infarction, cerebral hemorrhage, cerebral infarction, or active gastroduodenal ulcer.
- Convulsive disorders requiring anticonvulsants, ascites needing therapeutic puncture, or gastrointestinal obstruction.
- Inability to be hospitalized for up to 120 hours (Day 6) post-AC administration initiation.
- Any other conditions deemed inappropriate for study participation.
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2023
Estimated Enrollment :
442 Patients enrolled
Trial Details
Trial ID
NCT05242874
Start Date
February 1 2022
End Date
August 15 2023
Last Update
October 10 2024
Active Locations (2)
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1
Henan cacer hospital
Henan, Henan, China, 450008
2
Henan cancer hospital
Zhengzhou, Henan, China