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

Chemotherapy-induced Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05590923
• Other study ID #: 2209-47
• Status: Recruiting
• Phase: Phase 4
• Start date: December 7, 2022
• Est. completion date: November 1, 2024

Study information

• Verified date: February 2024
• Source: The Guthrie Clinic
• Contact: Zane Waite, PharmD, BCOP
• Phone: 570-887-6072
• Email: zane.waite[@]guthrie.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chemotherapy-induced Nausea and Vomiting
• Nausea
• Vomiting

Intervention

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).
• 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).

Locations

Country	Name	City	State
United States	Robert Packer Hospital	Sayre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
The Guthrie Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Total Control (TC- no emesis, no rescue medication, no nausea)	no emesis, no rescue medication, no nausea	120 hours following chemotherapy
Secondary	Severity of nausea and vomiting self-reported by patient questionnaire	None, mild or greater than mild	120 hours after chemotherapy
Secondary	medication side effects	medication side effects including sedation, insomnia, agitation, indigestion/heartburn, depression, anorexia, increased appetite/hunger and rash/acne	120 hours after chemotherapy