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

Sponsor

Simon Williamson Clinic (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06065722

Collaborator

Helsinn Healthcare SA (Industry)

100

Enrollment

Location

Arms

3.7

Anticipated Duration (Months)

26.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Chemotherapy Induced Nausea and Vomiting	Drug: Akynzeo	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

Double Blind

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Sep 9, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

COMPELETE RESPONSE, no vomiting or use of rescue medications [5 DAYS post chemotherapy]
No vomiting or use of rescue medications for 5 days post chemotherapy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rudolph M Navari	Mount Olive	Alabama	United States	35117

Sponsors and Collaborators

Simon Williamson Clinic
Helsinn Healthcare SA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Simon Williamson Clinic

ClinicalTrials.gov Identifier:

NCT06065722

Other Study ID Numbers:

SWC999

First Posted:

Oct 4, 2023

Last Update Posted:

Oct 10, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Simon Williamson Clinic

chemotherapy induced nausea and vomiting

NK-1

olanzapine

Additional relevant MeSH terms:

Nausea

Vomiting

Olanzapine

Study Results

No Results Posted as of Oct 10, 2023