Fosaprepitant , Tropisetron and Olanzapine for the Prevention of Nausea and Vomiting in Patients With Breast Cancer

  • End date
    Jun 1, 2024
  • participants needed
  • sponsor
    Henan Cancer Hospital
Updated on 3 May 2022


Standard antiemetic therapy without dexamethasone for the prevention of nausea and vomiting in patients with breast cancer


This is a multicenter, randomized, controlled, open-label, phase III study assessing the efficacy and safety of fosaprepitant, tropisetron and olanzapine for the Prevention of Nausea and Vomiting in Patients With Breast Cancer Receiving Anthracycline/Cyclophosphamide-containing Chemotherapy. Eligible patients will be randomized to receive either standard antiemetic therapy (fosaprepitant, tropisetron, dexamethasone and olanzapin) or standard antiemetic therapy without dexamethasone in a 1:1 ratio.

Condition Chemotherapy-induced Nausea and Vomiting
Treatment Fosaprepitant , Tropisetron and Olanzapine, Fosaprepitant , Tropisetron, Dexamethasoneand Olanzapine
Clinical Study IdentifierNCT05242874
SponsorHenan Cancer Hospital
Last Modified on3 May 2022


Yes No Not Sure

Inclusion Criteria

18-70 years of age; 2.Histologically or cytologically confirmed breast cancer; 3.Accept
chemotherapy for the first time; 4.Must be able to swallow tablets
Anthracycline/Cyclophosphamide-containing chemotherapy (adriamycin in combination with
cyclophosphamide ,cyclophosphamide ≤ 600mg/m2, adriamycin ≤ 60mg/m2, epirubicin ≤
mg/m2); 5.Written informed consent

Exclusion Criteria

Mentally disable or suffered from emotional disorders
Insulin dependent diabetes;
Pregnant or breastfeeding
Suffered from vomiting or nausea in the 24 hours before treatment
Narrow angle glaucoma;
Receive the following antiemetic agents within 48 hours before the first day of
treatment: 5-hydroxytryptamine 3 receptor antagonists (such as ondansetron)
phenothiazines, benzophenones (such as haloperidol), benzamide , domperidone
cannabinoids, herbs with potential antiemetic effects, scopolamine, and cyclizine
Receive benzodiazepines or opioids within 48 hours prior to the first day of the study
(except for triazolam, temazepam or midazolam single dose daily)
Symptomatic primary or metastatic central nervous system malignancies
Hypersensitivity to fosaprepitant, olanzapine, tropisetron or dexamethasone
History of concurrent abdominal radiotherapy
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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