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

Phase 4

Recruiting

• Conditions: Chemotherapy-induced Nausea and Vomiting

• Registration Number: NCT05590923
• Lead Sponsor: The Guthrie Clinic

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.

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 Timeline

• Study First Submitted: 2022-10-18
• Study First Submitted QC: 2022-10-18
• Study First Posted: 2022-10-21
• Study Start: 2022-12-07
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03
• Primary Completion: 2028-11-01
• Study Completion: 2029-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 104

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Complete response (CR) over 120 hours following chemotherapy	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Robert Packer Hospital; 🇺🇸 Sayre, Pennsylvania, United States