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

Sponsor

Henan Cancer Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05242874

Collaborator

(none)

403

Enrollment

Locations

Arms

Anticipated Duration (Months)

201.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chemotherapy-induced Nausea and Vomiting	Drug: Fosaprepitant , Tropisetron and Olanzapine Drug: Fosaprepitant , Tropisetron, Dexamethasoneand Olanzapine	Phase 3

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

403 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Standard antiemetic therapy without dexamethasone Olanzapine in combination with fosaprepitant and tropisetron	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 Other Names: Standard antiemetic therapy without dexamethasone
Active Comparator: Standard antiemetic therapy Olanzapine in combination with fosaprepitant, tropisetron and dexamethasone	Drug: Fosaprepitant , Tropisetron, Dexamethasoneand 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 Other Names: Standard antiemetic therapy

Arm

Intervention/Treatment

Experimental: Standard antiemetic therapy without dexamethasone

Olanzapine in combination with fosaprepitant and tropisetron

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

Other Names:

Standard antiemetic therapy without dexamethasone

Active Comparator: Standard antiemetic therapy

Olanzapine in combination with fosaprepitant, tropisetron and dexamethasone

Drug: Fosaprepitant , Tropisetron, Dexamethasoneand 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

Other Names:

Standard antiemetic therapy

Outcome Measures

Primary Outcome Measures

complete response rate in the acute (0-24 hours post-chemotherapy), delayed (24-120 hours post-chemotherapy) phase. [Day 1 to day 5 after highly emetogenic chemotherapy initiation]
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.

Secondary Outcome Measures

Complete control rate during the overall phase [Day 1 to day 5 after highly emetogenic chemotherapy initiation]
Complete control is defined as a condition where a patient shows no nausea or mild nausea
Total control rate during the overall phase [Day 1 to day 5 after highly emetogenic chemotherapy initiation]
Total control is defined as a condition where a patient neither shows nausea nor vomiting.
To compare quality of life using the functional living index-emesis questionnaire [Day 1 to day 5 after highly emetogenic chemotherapy initiation]
No (or minimal) Impact on patient's Daily Life (NIDL) is generally considered a score ≥54 (6 points mean for each item)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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, etc;
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;