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

Chemotherapy-induced Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05242874
• Other study ID #: HELEN-009
• Status: Completed
• Phase: Phase 3
• Start date: January 1, 2022
• Est. completion date: August 15, 2023

Study information

• Verified date: April 2024
• Source: Henan Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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 olanzapine) or standard antiemetic therapy without dexamethasone in a 1:1 ratio.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 442
• Est. completion date: August 15, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1.18-70 years of age; 2.Histologically or cytologically confirmed breast cancer; 3.Accept chemotherapy for the first time; 4.Must be able to swallow tablets 4.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. Mentally disable or suffered from emotional disorders;

2. Insulin dependent diabetes;

3. Pregnant or breastfeeding;

4. Suffered from vomiting or nausea in the 24 hours before treatment;

5. Narrow angle glaucoma;

6. 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, etc;

7. 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. Symptomatic primary or metastatic central nervous system malignancies;

9. Hypersensitivity to fosaprepitant, olanzapine, tropisetron or dexamethasone;

10. History of concurrent abdominal radiotherapy;

Related Conditions & MeSH terms

• Chemotherapy-induced Nausea and Vomiting
• Nausea
• Vomiting

Intervention

Drug:
• Fosaprepitant , Tropisetron and Olanzapine
fosaprepitant 150mg i.v. on day 1 before undergoing chemotherapy. tropisetron 5mg i.v. on day 1 before undergoing chemotherapy. olanzapine 5mg p.o. on day 1-4
• Fosaprepitant , Tropisetron, Dexamethasone and Olanzapine
On first day, dexamethasone (12 mg) is given orally/intravenously within 30 minutes before cisplatin administrated, and on day 2-4, the given dose of dexamethasone is 8 mg. fosaprepitant 150mg i.v. on day 1 before undergoing chemotherapy. tropisetron 5mg i.v. on day 1 before undergoing chemotherapy. olanzapine 5mg p.o. on day 1-4

Locations

Country	Name	City	State
China	Henan cacer hospital	Henan	Henan
China	Henan cancer hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete response rate in the acute (0-24 hours post-chemotherapy), delayed (24-120 hours post-chemotherapy) phase.	Complete response is defined as a condition in which a patient does not show vomiting or retching and does not require additional treatment with antiemetics. Retching is defined as the physical reaction that accompanies vomiting in the absence of gastric content ejection.	Day 1 to day 5 after highly emetogenic chemotherapy initiation
Secondary	Complete control rate during the overall phase	Complete control is defined as a condition where a patient shows no nausea or mild nausea	Day 1 to day 5 after highly emetogenic chemotherapy initiation
Secondary	Total control rate during the overall phase	Total control is defined as a condition where a patient neither shows nausea nor vomiting.	Day 1 to day 5 after highly emetogenic chemotherapy initiation
Secondary	To compare quality of life using the functional living index-emesis questionnaire	No (or minimal) Impact on patient's Daily Life (NIDL) is generally considered a score =54 (6 points mean for each item)	Day 1 to day 5 after highly emetogenic chemotherapy initiation