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

The Efficacy of Steroid-Sparing Anti-Emetic Therapy in Patients Treated With High or Moderate Emetogenic Chemotherapy; Single Center Non-Inferiority Open Label Randomized Controlled Trial

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.

Study Overview

• Status: Terminated
• Conditions: Chemotherapy-induced Nausea and Vomiting
• Intervention / Treatment: Drug: OLA group: Olanzapine; Drug: DEX group: Dexamethasone

Detailed Description

The study will include patients treated with high emetogenic chemotherapy (HEC) or moderate emetogenic chemotherapy (MEC). Emetogenic means that it may cause nausea and vomiting. Your participation will last for 2 cycles of chemotherapy.

For patients given high emetogenic chemotherapy (HEC):

As standard of care for nausea and vomiting after high emetogenic chemotherapy (HEC), subjects will receive fosaprepitant 150 mg IV once, palonosetron 0.25 mg IV once, dexamethasone 12 mg oral or IV once on day 1.

Patients 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.

1. DEX group: dexamethasone (Decadron) 8 mg oral daily on days 2-4.
2. OLA group: olanzapine (Zyprexa)10 mg oral each night on days 1-4. For the second cycle of chemotherapy, the subject will switch to the other group. For future cycles of chemotherapy, the subject will choose the drug that worked best.

For patients give moderate emetogenic chemotherapy (MEC):

As standard of care for nausea and vomiting after moderate emetogenic chemotherapy (MEC), subjects will receive granisetron 2 mg oral once and, dexamethasone 12 mg oral once on day 1.

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.

1. DEX group: dexamethasone (Decadron) 8 mg oral daily on days 2-3.
2. OLA group: olanzapine (Zyprexa)10 mg oral each night on days 1-3. For the second cycle of chemotherapy, the subject will switch to the other group. For future cycles of chemotherapy, the subject will choose the drug that worked best.

Subjects (both HEC and MEC) will be asked to complete a survey prior to treatment on Day 1 of cycle 1 and cycle 2 prior to treatment. On Day 2 and Day 6 a member of the study will contact subjects by phone to complete another survey on any symptoms you may be experiencing.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Sayre, Pennsylvania, United States, 18840
      • Robert Packer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OLA then crossover to DEX; 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; 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).; Other Names: Steroid-sparing therapy; Drug: DEX group: Dexamethasone; 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).; Other Names: Steroid therapy
Active Comparator: DEX then crossover to OLA; 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; 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).; Other Names: Steroid-sparing therapy; Drug: DEX group: Dexamethasone; 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).; Other Names: Steroid therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete control (CC- no emesis, no rescue medication and no more than minimal nausea)	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)	no emesis, no rescue medication, no nausea	120 hours following chemotherapy
Severity of nausea and vomiting self-reported by patient questionnaire	None, mild or greater than mild	120 hours after chemotherapy
medication side effects	medication side effects including sedation, insomnia, agitation, indigestion/heartburn, depression, anorexia, increased appetite/hunger and rash/acne	120 hours after chemotherapy

Collaborators and Investigators

• Sponsor: The Guthrie Clinic
• Investigators: Principal Investigator: Zane Waite, PharmD, BCOP, The Guthrie Clinic

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2022
• Primary Completion (Actual): July 8, 2025
• Study Completion (Actual): July 8, 2025

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Estimated): October 31, 2025
• Last Update Submitted That Met QC Criteria: October 30, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Vomiting; Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Central Nervous System Depressants; Neurotransmitter Agents; Membrane Transport Modulators; Tranquilizing Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Serotonin Agents; Selective Serotonin Reuptake Inhibitors; Antipsychotic Agents; Olanzapine; Dexamethasone
• Other Study ID Numbers: 2209-47

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