CompletedPhase 3

Anti-emetic Prophylaxis With or Without Dexamethasone

China442 participantsStarted 2022-02-01

Plain-language 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 epirubicin and cyclophosphamide.

Who can participate

Age range18 Years – 70 Years

SexFEMALE

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Complete response rate (CR) during overall (0-120 hours after the initiation of anthracycline/cyclophosphamide administration) phase.

Timeframe: 0-120 hours after the initiation of anthracycline/cyclophosphamide administration

Trial details

NCT IDNCT05242874

SponsorHenan Cancer Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2023-08-15

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