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

Study Overview
=================
Brief Summary
-----------------
Standard antiemetic therapy without dexamethasone for the prevention of nausea and vomiting in patients with breast cancer

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

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

Conditions
-----------------
Chemotherapy-induced Nausea and Vomiting

Intervention / Treatment
-----------------
* Drug: Fosaprepitant , Tropisetron and Olanzapine
* Drug: Fosaprepitant , Tropisetron, Dexamethasone and Olanzapine


Participation Criteria
=================
Eligibility Criteria
-----------------
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;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard antiemetic therapy without dexamethasone<br>Olanzapine in combination with fosaprepitant and tropisetron | Drug: Fosaprepitant , Tropisetron and Olanzapine<br>* 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<br>* Other names: Standard antiemetic therapy without dexamethasone;|
| Active Comparator: Standard antiemetic therapy<br>Olanzapine in combination with fosaprepitant, tropisetron and dexamethasone | Drug: Fosaprepitant , Tropisetron, Dexamethasone and Olanzapine<br>* 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<br>* Other names: Standard antiemetic therapy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nausea, Vomiting, Glucocorticoids, Olanzapine, Tropisetron, Fosaprepitant, Signs and Symptoms, Digestive, Antiemetics, Physiological Effects of Drugs