Fosaprepitant , Tropisetron and Olanzapine for the Prevention of Nausea and Vomiting in Patients With Breast Cancer Receiving Anthracycline/Cyclophosphamide-containing Chemotherapy

• Status: Active, not recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henan Cancer Hospital
• Treatments: Aprepitant; Fosaprepitant; Olanzapine; Tropisetron

Criteria

Inclusion Criteria:

1.18-70 years of age; 2.Histologically or cytologically confirmed breast cancer; 3.Accept chemotherapy for the first time; 4.Patients who will receive Anthracycline/Cyclophosphamide-containing chemotherapy (adriamycin in combination with cyclophosphamide ,cyclophosphamide ≤ 600mg/m2, adriamycin ≤ 60mg/m2, epirubicin ≤ 100mg/m2); 5.Written informed consent.

Exclusion Criteria:

1. Patients were mentally disable or suffered from emotional disorders;

2. Patients have any disease that the researcher believes may confound the results of the study or expose the patient to unnecessary risk；

3. Patients were pregnant or breastfeeding;

4. Patients had suffered from vomiting or nausea in the 24 hours before treatment;

5. Patients were known to be at risk for narrow angle glaucoma；

6. Within 48 hours before the first day of treatment, patients used the following antiemetic agents: 5-hydroxytryptamine 3 receptor antagonists (such as ondansetron), phenothiazines, benzophenones (such as haloperidol), benzamide , domperidone, cannabinoids, herbs with potential antiemetic effects, scopolamine, and cyclizine, etc;

7. Patients began to receive benzodiazepines or opioids within 48 hours prior to the first day of the study (except for triazolam, temazepam or midazolam single dose daily);

8. Patients had symptomatic primary or metastatic central nervous system malignancies;

9. Patients had concomitant diseases that could not take dexamethasone for 4 days, such as uncontrolled diabetes mellitus;

10. Patients had a history of hypersensitivity to fosaprepitant, olanzapine, tropisetron or dexamethasone；

11. Patients were Inability or unwillingness to understand or cooperate with study procedures;

12. Patients had a history of concurrent abdominal radiotherapy.