Steroid-sparing Therapy (Olanzapine) Versus Dexamethasone-based Therapy for Chemotherapy-induced Nausea and Vomiting

NCT05590923 | Terminated Phase 4 FDA Drug

• 1 other identifier: 2209-47
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to compare two drugs that are routinely used as standard of care for treating nausea and vomiting caused by chemotherapy. This study aims to see if the drug olanzapine is as good as the steroid drug dexamethasone for preventing nausea and vomiting after chemotherapy. Both drugs are listed as appropriate treatment options in the most recent version of National Comprehensive Cancer Network guidelines on Antiemesis.

Conditions

Chemotherapy-induced Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• Complete response (CR) over 120 hours following chemotherapy

  Complete response (CR) over 120 hours following chemotherapy, where CR is the absence of emesis and no use of a rescue antiemetic medication, in the acute phase (\<24 hours following chemotherapy), delayed phase (≥24 hours but ≤120 hours following chemotherapy) and overall (≤ 120 hours following chemotherapy).

  120 hours following chemotherapy

Secondary Outcomes (4)

• Complete control (CC- no emesis, no rescue medication and no more than minimal nausea)

  120 hours following chemotherapy

• Total Control (TC- no emesis, no rescue medication, no nausea)

  120 hours following chemotherapy

• Severity of nausea and vomiting self-reported by patient questionnaire

  120 hours after chemotherapy

• medication side effects

  120 hours after chemotherapy

Study Arms (2)

OLA then crossover to DEX

EXPERIMENTAL

OLA group: olanzapine (Zyprexa) 10 mg oral each night after chemotherapy cycle 1 on days 1-4 after HEC (or days 1-3 after MEC). DEX group: dexamethasone (Decadron) 8 mg oral daily after chemotherapy cycle 2 on days 2-4 after HEC (or days 2-3 after MEC)

Drug: OLA group: Olanzapine; Drug: DEX group: Dexamethasone

DEX then crossover to OLA

ACTIVE COMPARATOR

DEX group: dexamethasone (Decadron) 8 mg oral daily after chemotherapy cycle 1 on days 2-4 after HEC (or days 2-3 after MEC) OLA group: olanzapine (Zyprexa) 10 mg oral each night after chemotherapy cycle 2 on days 1-4 after HEC (or days 1-3 after MEC).

Drug: OLA group: Olanzapine; Drug: DEX group: Dexamethasone

Interventions

OLA group: Olanzapine DRUG

OLA group: olanzapine 10 mg oral each night on days 1-4 after HEC (or days 1-3 after MEC). DEX group: dexamethasone (Decadron) 8 mg oral daily on days 2-4 after HEC (or days 2-3 after MEC).

Also known as: Steroid-sparing therapy

DEX then crossover to OLA; OLA then crossover to DEX

DEX group: Dexamethasone DRUG

DEX group: dexamethasone (Decadron) 8 mg oral daily on days 2-4 after HEC (or days 2-3 after MEC).. OLA group: olanzapine 10 mg oral each night on days 1-4 after HEC (or days 1-3 after MEC).

Also known as: Steroid therapy

DEX then crossover to OLA; OLA then crossover to DEX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older
• confirmed cancer diagnosis
• starting cycle 1 of an FDA approved treatment that is categorized as high-emetogenic (nausea and vomiting inducing) chemotherapy per National Comprehensive Cancer Network® guidelines
• Eastern Cooperative Oncology Group performance score of 0 or 1
• appropriate renal function
• appropriate hepatic function
• appropriate hematologic function.

You may not qualify if:

• Patients will be excluded if they experience nausea or vomiting up to 24 hours before chemotherapy,
• currently on a glucocorticoid therapy
• contraindication to glucocorticoid therapy
• taking any medication that has antiemetic properties.
• scheduled or planned to receive radiation within one week of or concurrently with chemotherapy
• brain metastases.

Sponsors & Collaborators

• The Guthrie Clinic: lead

Study Sites (1)

Robert Packer Hospital

Sayre, Pennsylvania, 18840, United States

Location

MeSH Terms

Conditions

Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zane Waite, PharmD, BCOP

  The Guthrie Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will be randomly assigned to either the DEX group to receive dexamethasone or to the OLA group to receive olanzapine for the first cycle of chemotherapy. DEX group: dexamethasone (Decadron) 8 mg oral daily on days 2-4 after HEC (days 2-3 after MEC). OLA group: olanzapine (Zyprexa)10 mg oral each night on days 1-4 after HEC (days 2-3 after MEC). For the second cycle of chemotherapy, the subject will switch to the other group. Groups: OLA then DEX; DEX then OLA

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 21, 2022
• Study Start: December 7, 2022
• Primary Completion: July 8, 2025
• Study Completion: July 8, 2025
• Last Updated: October 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)