Prevention of Breakthrough CINV in Patients Receiving Moderately or Highly Emetogenic Chemotherapy

Study Overview
=================
Brief Summary
-----------------
The purpose of the proposed study is to provide a clinical approach to chemotherapy induced nausea and vomiting (CINV) prophylaxis in cycle 2 of moderately emetogenic chemotherapy or highly emetogenic chemotherapy for patients who developed breakthrough CINV after cycle 1 based on the available data in the literature as well as the recommendations provided by established guidelines

Detailed Description
-----------------
Chemotherapy-induced nausea and vomiting (CINV) adversely affects patients' quality of life and may affect patients' treatment decisions. The emetogenicity of the chemotherapy administered and specific patient characteristics such as female gender, age, and history of low alcohol intake can increase a patients' risk for CINV. Table 1. Patient-Related Risk Factors for Emesis Following Chemotherapy Major Factors Minor Factors Female History of Motion Sickness Age < 50 years Emesis during past pregnancy History of prior low chronic alcohol intake (<1 ounce of alcohol/day) Anxiety History of previous chemotherapy-induced emesis Significant and uncontrolled CINV may result in patients returning to the chemotherapy treatment facility one to three days post-chemotherapy for rehydration, or emesis or nausea control. If CINV cannot be controlled in an outpatient facility, patients may subsequently be treated in an emergency department or require hospitalization. Patients who have an electrolyte imbalance or those who have recently undergone surgery or radiation therapy, are at greater risk of experiencing serious complications from CINV. The use of 5-hydroxytryptamine-3 (5-HT3) receptor antagonists has improved the control of CINV Additional improvement in the control of CINV has occurred with the use of neurokinin-1 (NK-1) receptor antagonists, and olanzapine, an antipsychotic which blocks multiple neurotransmitters in the central nervous system. The primary endpoint used for studies evaluating various agents for the control of CINV has been complete response (CR) (no emesis, no use of rescue medication) over the acute (24 hours post-chemotherapy), delayed (24-120 hours), and overall (0-120 hours) periods. The combination of a 5-HT3 receptor antagonist, dexamethasone, and a NK-1 receptor antagonist have improved the control of emesis in patients receiving either highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC) over a 120-hour period following chemotherapy administration The use of effective antiemetic agents in various clinical settings has been described in established guidelines from the Multinational Association of Supportive Care in Cancer (MASCC) and the European Society of Medical Oncology (ESMO), the American Society of Clinical Oncology (ASCO)], and the National Comprehensive Cancer Network (NCCN). The purpose of the proposed is to provide a clinical approach to CINV prophylaxis in cycle 2 of MEC or HEC for patients who developed breakthrough CINV after cycle 1 based on the available data in the literature as well as the recommendations provided by established guidelines.

Official Title
-----------------
Akynzeo or Olanzapine for Patients Who Experience Breakthrough CINV in Patient Receiving Moderately or Highly Emetogenic Chemotherapy After First Cycle of Chemotherapy

Conditions
-----------------
Chemotherapy Induced Nausea and Vomiting

Intervention / Treatment
-----------------
* Drug: Akynzeo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CHEMOTHERAPY NAIIVE patient receiving moderately or highly emetogenic chemotherapy lung cancer breast cancer Exclusion Criteria: PRIOR CHEMOTHERAPY for any cancer nausea or vomiting 24 hours prior to study entry

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

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AKYNZEO for patient receiving MEC<br>Add Akynzeo to 5HT3 And dexamethasone | Drug: Akynzeo<br>* OLANZAPINE<br>* Other names: Olanzapine;|
| Active Comparator: oLANZAPINE and Akynzeo to patients receiving highly emetogenic<br>olANZAPINE plus Akynzeo | Drug: Akynzeo<br>* OLANZAPINE<br>* Other names: Olanzapine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COMPELETE RESPONSE, no vomiting or use of rescue medications | No vomiting or use of rescue medications for 5 days post chemotherapy | 5 DAYS post chemotherapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chemotherapy induced nausea and vomiting, NK-1, olanzapine