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Terminated

NCT Number: NCT05590923

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

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.

Why the study stopped: Study stopped due to lower than expected accrual.
Terminated

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Robert Packer Hospital

Sayre, Pennsylvania, 18840, United States

About this study

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.

  • 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. 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.

  • DEX group: dexamethasone (Decadron) 8 mg oral daily on days 2-3.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Other names: Steroid-sparing therapy

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).

Other names: Steroid therapy

Primary outcomes

  1. Number of Patients With Complete Response (CR) Over 120 Hours Following Chemotherapy

    Time frame: 120 hours following chemotherapy

    The number of patients with 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). Chemotherapy cycle length varied depending on the physician's decision, congruent with standard-of-care protocols for each cancer type.

Secondary outcomes

  1. Number of Patients With Complete Control (CC) Over 120 Hours Following Chemotherapy

    Time frame: 120 hours following chemotherapy

    The number of patients with Complete response (CC) over 120 hours following chemotherapy, where CC is no emesis, no rescue medication and no more than minimal nausea, in the acute phase (<24 hours following chemotherapy), delayed phase (≥24 hours but ≤120 hours following chemotherapy) and overall (≤ 120 hours following chemotherapy). Chemotherapy cycle length varied depending on the physician's decision, congruent with standard-of-care protocols for each cancer type.

  2. Number of Patients With Total Control (TC) Over 120 Hours Following Chemotherapy

    Time frame: 120 hours following chemotherapy

    The number of patients with Total control (TC) over 120 hours following chemotherapy, where TC is no emesis, no rescue medication, no nausea, in the acute phase (<24 hours following chemotherapy), delayed phase (≥24 hours but ≤120 hours following chemotherapy) and overall (≤ 120 hours following chemotherapy). Chemotherapy cycle length varied depending on the physician's decision, congruent with standard-of-care protocols for each cancer type.

Other outcomes

  1. Severity of Nausea and Vomiting Self-reported by Patient Questionnaire

    Time frame: 120 hours after chemotherapy

    The number of patients who reported severity of nausea and vomiting within 120 hours after chemotherapy through a self-reported questionnaire in which nausea was assessed on a Likert scale as none, mild or greater than mild. Chemotherapy cycle length varied depending on the physician's decision, congruent with standard-of-care protocols for each cancer type.

  2. Sedation (Medication Side Effect)

    Time frame: 120 hours after chemotherapy

    The number of patients who identified as experiencing the medication side effect of sedation within 120hrs of chemotherapy. Chemotherapy cycle length varied depending on the physician's decision, congruent with standard-of-care protocols for each cancer type.

  3. Insomnia (Medication Side Effect)

    Time frame: 120 hours after chemotherapy

    The number of patients who identified as experiencing the medication side effect of insomnia within 120hrs of chemotherapy. Chemotherapy cycle length varied depending on the physician's decision, congruent with standard-of-care protocols for each cancer type.

  4. Agitation (Medication Side Effect)

    Time frame: 120 hours after chemotherapy

    The number of patients who identified as experiencing the medication side effect of agitation within 120hrs of chemotherapy. Chemotherapy cycle length varied depending on the physician's decision, congruent with standard-of-care protocols for each cancer type.

  5. Indigestion (Medication Side Effect)

    Time frame: 120 hours after chemotherapy

    The number of patients who identified as experiencing the medication side effect of indigestion within 120hrs of chemotherapy. Chemotherapy cycle length varied depending on the physician's decision, congruent with standard-of-care protocols for each cancer type.

  6. Depression (Medication Side Effect)

    Time frame: 120 hours after chemotherapy

    The number of patients who identified as experiencing the medication side effect of depression within 120hrs of chemotherapy. Chemotherapy cycle length varied depending on the physician's decision, congruent with standard-of-care protocols for each cancer type.

  7. Increased Appetite (Medication Side Effect)

    Time frame: 120 hours after chemotherapy

    The number of patients who identified as experiencing the medication side effect of increased appetite within 120hrs of chemotherapy. Chemotherapy cycle length varied depending on the physician's decision, congruent with standard-of-care protocols for each cancer type.

  8. Decreased Appetite (Medication Side Effect)

    Time frame: 120 hours after chemotherapy

    The number of patients who identified as experiencing the medication side effect of decreased appetite within 120hrs of chemotherapy. Chemotherapy cycle length varied depending on the physician's decision, congruent with standard-of-care protocols for each cancer type.

  9. Rash (Medication Side Effect)

    Time frame: 120 hours after chemotherapy

    The number of patients who identified as experiencing the medication side effect of rash within 120hrs of chemotherapy. Chemotherapy cycle length varied depending on the physician's decision, congruent with standard-of-care protocols for each cancer type.

Sponsors and collaborators

Lead sponsor

The Guthrie Clinic

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 21, 2022
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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