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

Chemotherapy Induced Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06065722
• Other study ID #: SWC999
• Status: Recruiting
• Phase: Phase 2
• Start date: September 9, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2023
• Source: Simon Williamson Clinic
• Contact: Rudolph M Navari
• Phone: 5742618385
• Email: rmnavari[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy Induced Nausea and Vomiting
• Nausea
• Vomiting

Intervention

Drug:
• Akynzeo
OLANZAPINE

Locations

Country	Name	City	State
United States	Rudolph M Navari	Mount Olive	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
Simon Williamson Clinic	Helsinn Healthcare SA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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