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

October 8, 2023 updated by: Simon Williamson Clinic

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Mount Olive, Alabama, United States, 35117
        • Recruiting
        • Rudolph M Navari
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: AKYNZEO for patient receiving MEC
Add Akynzeo to 5HT3 And dexamethasone
Drug: Akynzeo
OLANZAPINE
Other Names:
  • Olanzapine
Active Comparator: oLANZAPINE and Akynzeo to patients receiving highly emetogenic
olANZAPINE plus Akynzeo
Drug: Akynzeo
OLANZAPINE
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
Time Frame: 5 DAYS post chemotherapy
No vomiting or use of rescue medications for 5 days post chemotherapy
5 DAYS post chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Simon Williamson Clinic

Collaborators

Helsinn Healthcare SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2023

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

September 24, 2023

First Submitted That Met QC Criteria

October 1, 2023

First Posted (Actual)

October 4, 2023

Study Record Updates

Last Update Posted (Estimated)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 8, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SWC999

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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