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

Sponsor
The Guthrie Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05590923
Collaborator
(none)
104
Enrollment
1
Location
2
Arms
22.8
Anticipated Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: OLA group: Olanzapine
  • Drug: DEX group: Dexamethasone
 Phase 4

Detailed Description

As standard of care for nausea and vomiting after chemotherapy, subjects will receive fosaprepitant 150 mg IV once, palonosetron 0.25 mg IV once, dexamethasone 12 mg oral or IV 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 2-4.

  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.

Subjects 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 Design

Study Type:
Interventional
Anticipated Enrollment :
104 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
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. 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. Groups: OLA then DEX; DEX then OLASubjects 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. 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.Groups:OLA then DEX; DEX then OLA
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Efficacy of Steroid-Sparing Anti-Emetic Therapy in Patients Treated With High Emetogenic Chemotherapy; Single Center Non-Inferiority Open Label Randomized Controlled Trial
Actual Study Start Date :
Dec 7, 2022
Anticipated Primary Completion Date :
Nov 1, 2024
Anticipated Study Completion Date :
Nov 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: OLA then crossover to DEX

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

Drug: OLA group: Olanzapine
OLA group: olanzapine 10 mg oral each night on days 2-4. DEX group: dexamethasone (Decadron) 8 mg oral daily on days 2-4.
Other Names:
  • Steroid-sparing therapy

    • Drug: DEX group: Dexamethasone
    DEX group: dexamethasone (Decadron) 8 mg oral daily on days 2-4. OLA group: olanzapine 10 mg oral each night on days 2-4.
    Other Names:
  • Steroid therapy

    		•
    Active Comparator: DEX then crossover to OLA

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

    Drug: OLA group: Olanzapine
    OLA group: olanzapine 10 mg oral each night on days 2-4. DEX group: dexamethasone (Decadron) 8 mg oral daily on days 2-4.
    Other Names:
  • Steroid-sparing therapy

    • Drug: DEX group: Dexamethasone
    DEX group: dexamethasone (Decadron) 8 mg oral daily on days 2-4. OLA group: olanzapine 10 mg oral each night on days 2-4.
    Other Names:
  • Steroid therapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. Total Control (TC- no emesis, no rescue medication, no nausea) [120 hours following chemotherapy]

      no emesis, no rescue medication, no nausea

    3. Severity of nausea and vomiting self-reported by patient questionnaire [120 hours after chemotherapy]

      None, mild or greater than mild

    4. medication side effects [120 hours after chemotherapy]

      medication side effects including sedation, insomnia, agitation, indigestion/heartburn, depression, anorexia, increased appetite/hunger and rash/acne

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Robert Packer Hospital Sayre Pennsylvania United States 18840

    Sponsors and Collaborators

    • The Guthrie Clinic

    Investigators

    • Principal Investigator: Nicole Ink, PharmD, The Guthrie Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The Guthrie Clinic
    ClinicalTrials.gov Identifier:
    NCT05590923
    Other Study ID Numbers:
    • 2209-47
    First Posted:
    Oct 21, 2022
    Last Update Posted:
    Jan 13, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Nausea
    Vomiting
    Dexamethasone
    Olanzapine

    Study Results

    No Results Posted as of Jan 13, 2023