Recruiting
Phase 2

Breakthrough CINV

Sponsor:

Simon Williamson Clinic

Code:

NCT06065722

Conditions

Chemotherapy Induced Nausea and Vomiting

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Akynzeo

Study Details

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

Conditions

Chemotherapy Induced Nausea and Vomiting

Study ID

NCT06065722

Start date

Sep 9, 2023

Status verified date

Sep, 2023

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: AKYNZEO for patient receiving MEC

Add Akynzeo to 5HT3 And dexamethasone

active comparator: oLANZAPINE and Akynzeo to patients receiving highly emetogenic

olANZAPINE plus Akynzeo

Interventions

Akynzeo

OLANZAPINE

Primary outcome measure

  • COMPELETE RESPONSE, no vomiting or use of rescue medications [ Time Frame: 5 DAYS post chemotherapy ]

Central Contacts and Locations

Central contacts

Rudolph M Navari

5742618385rmnavari@gmail.com

Locations

Rudolph M Navari

Recruiting

Mount Olive, Alabama, United States, 35117

Contacts

Rudolph M Navari

574-261-8385rmnavari@gmail.com

Rudolph M Navari

5742618385rmnavari@gmail.com

More Information

Sponsor

Simon Williamson Clinic

Last update posted

Oct 10, 2023

Last verified

Sep, 2023

Keywords

  • chemotherapy induced nausea and vomiting
  • NK-1
  • olanzapine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Simon Williamson Clinic on 2023-10-10.