Trial Outcomes & Findings for Steroid-sparing Therapy (Olanzapine) Versus Dexamethasone-based Therapy for Chemotherapy-induced Nausea and Vomiting (NCT NCT05590923)
NCT ID: NCT05590923
Last Updated: 2026-09-02
Results Overview
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.
TERMINATED
PHASE4
23 participants
120 hours following chemotherapy
2026-09-02
Participant Flow
Participant milestones
| Measure |
DEX Then Crossover to OLA
Participants in this arm will begin DEX (dexamethasone) on Cycle 1, then crossover to OLA (olanzapine) on Cycle 2.
Cycle 1: dexamethasone (Decadron) 8 mg oral daily after chemotherapy cycle 1 on days 2-4 after HEC (or days 2-3 after MEC) Cycle 2: olanzapine 10 mg oral each night after chemotherapy cycle 2 on days 1-4 after HEC (or days 1-3 after MEC).
|
OLA Then Crossover to DEX
Participants in this arm will begin OLA (olanzapine) on Cycle 1, then crossover to DEX (dexamethasone) on Cycle 2.
Cycle 1: Olanzapine (Zyprexa) 10 mg oral each night after chemotherapy cycle 1 on days 1-4 after HEC (or days 1-3 after MEC).
Cycle 2: Dexamethasone (Decadron) 8 mg oral daily after chemotherapy cycle 2 on days 2-4 after HEC (or days 2-3 after MEC)
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
|
Overall Study
COMPLETED
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
DEX Then Crossover to OLA
Participants in this arm will begin DEX (dexamethasone) on Cycle 1, then crossover to OLA (olanzapine) on Cycle 2.
Cycle 1: dexamethasone (Decadron) 8 mg oral daily after chemotherapy cycle 1 on days 2-4 after HEC (or days 2-3 after MEC) Cycle 2: olanzapine 10 mg oral each night after chemotherapy cycle 2 on days 1-4 after HEC (or days 1-3 after MEC).
|
OLA Then Crossover to DEX
Participants in this arm will begin OLA (olanzapine) on Cycle 1, then crossover to DEX (dexamethasone) on Cycle 2.
Cycle 1: Olanzapine (Zyprexa) 10 mg oral each night after chemotherapy cycle 1 on days 1-4 after HEC (or days 1-3 after MEC).
Cycle 2: Dexamethasone (Decadron) 8 mg oral daily after chemotherapy cycle 2 on days 2-4 after HEC (or days 2-3 after MEC)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Physician Decision
|
3
|
0
|
|
Overall Study
Protocol Violation
|
1
|
1
|
Baseline Characteristics
Steroid-sparing Therapy (Olanzapine) Versus Dexamethasone-based Therapy for Chemotherapy-induced Nausea and Vomiting
Baseline characteristics by cohort
| Measure |
DEX Then Crossover to OLA
n=12 Participants
Participants in this arm will begin DEX (dexamethasone) on Cycle 1, then crossover to OLA (olanzapine) on Cycle 2. Cycle 1: dexamethasone (Decadron) 8 mg oral daily after chemotherapy cycle 1 on days 2-4 after HEC (or days 2-3 after MEC) Cycle 2: olanzapine 10 mg oral each night after chemotherapy cycle 2 on days 1-4 after HEC (or days 1-3 after MEC).
|
OLA Then Crossover to DEX
n=11 Participants
Participants in this arm will begin OLA (olanzapine) on Cycle 1, then crossover to DEX (dexamethasone) on Cycle 2. Cycle 1: Olanzapine (Zyprexa) 10 mg oral each night after chemotherapy cycle 1 on days 1-4 after HEC (or days 1-3 after MEC). Cycle 2: Dexamethasone (Decadron) 8 mg oral daily after chemotherapy cycle 2 on days 2-4 after HEC (or days 2-3 after MEC)
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=136 Participants
|
2 Participants
n=136 Participants
|
8 Participants
n=272 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=136 Participants
|
9 Participants
n=136 Participants
|
15 Participants
n=272 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=136 Participants
|
8 Participants
n=136 Participants
|
15 Participants
n=272 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=136 Participants
|
3 Participants
n=136 Participants
|
8 Participants
n=272 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=136 Participants
|
1 Participants
n=136 Participants
|
1 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=136 Participants
|
10 Participants
n=136 Participants
|
22 Participants
n=272 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
PRIMARY outcome
Timeframe: 120 hours following chemotherapyPopulation: Study was terminated without statistical analysis.
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.
Outcome measures
| Measure |
DEX (Dexamethasone)
n=23 Participants
Participants in this arm received dexamethasone (Decadron) 8 mg oral daily following chemotherapy cycle 1 or 2, on days 2-4 after HEC (or days 2-3 after MEC).
|
OLA (Olanzapine)
n=23 Participants
Participants in this arm received olanzapine (Zyprexa) 10 mg oral each night following chemotherapy cycle 1 or 2, on days 1-4 after HEC (or days 1-3 after MEC).
|
|---|---|---|
|
Number of Patients With Complete Response (CR) Over 120 Hours Following Chemotherapy
|
9 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 120 hours following chemotherapyPopulation: Study was terminated without statistical analysis.
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.
Outcome measures
| Measure |
DEX (Dexamethasone)
n=23 Participants
Participants in this arm received dexamethasone (Decadron) 8 mg oral daily following chemotherapy cycle 1 or 2, on days 2-4 after HEC (or days 2-3 after MEC).
|
OLA (Olanzapine)
n=23 Participants
Participants in this arm received olanzapine (Zyprexa) 10 mg oral each night following chemotherapy cycle 1 or 2, on days 1-4 after HEC (or days 1-3 after MEC).
|
|---|---|---|
|
Number of Patients With Complete Control (CC) Over 120 Hours Following Chemotherapy
|
9 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 120 hours following chemotherapyPopulation: Study was terminated without statistical analysis.
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.
Outcome measures
| Measure |
DEX (Dexamethasone)
n=23 Participants
Participants in this arm received dexamethasone (Decadron) 8 mg oral daily following chemotherapy cycle 1 or 2, on days 2-4 after HEC (or days 2-3 after MEC).
|
OLA (Olanzapine)
n=23 Participants
Participants in this arm received olanzapine (Zyprexa) 10 mg oral each night following chemotherapy cycle 1 or 2, on days 1-4 after HEC (or days 1-3 after MEC).
|
|---|---|---|
|
Number of Patients With Total Control (TC) Over 120 Hours Following Chemotherapy
|
8 Participants
|
10 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 120 hours after chemotherapyPopulation: All participants who received intervention dose and responded to the post-treatment questionnaire. Not all patients responded to the survey questions so there were fewer responses collected than there were patients surveyed. Of the patients in Arm A (DEX), 19 responded to the survey questions and in Arm B (OLA), 17 responded to the survey questions. Study was terminated without statistical analysis.
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.
Outcome measures
| Measure |
DEX (Dexamethasone)
n=19 Participants
Participants in this arm received dexamethasone (Decadron) 8 mg oral daily following chemotherapy cycle 1 or 2, on days 2-4 after HEC (or days 2-3 after MEC).
|
OLA (Olanzapine)
n=17 Participants
Participants in this arm received olanzapine (Zyprexa) 10 mg oral each night following chemotherapy cycle 1 or 2, on days 1-4 after HEC (or days 1-3 after MEC).
|
|---|---|---|
|
Severity of Nausea and Vomiting Self-reported by Patient Questionnaire
None
|
12 Participants
|
11 Participants
|
|
Severity of Nausea and Vomiting Self-reported by Patient Questionnaire
Mild
|
5 Participants
|
6 Participants
|
|
Severity of Nausea and Vomiting Self-reported by Patient Questionnaire
Greater than Mild
|
2 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 120 hours after chemotherapyPopulation: All participants who received intervention dose and responded to the post-treatment questionnaire. Not all patients responded to the survey questions so there were fewer responses collected than there were patients surveyed. Of the patients in Arm A (DEX), 18 responded to the survey questions and in Arm B (OLA), 18 responded to the survey questions. Study was terminated without statistical analysis.
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.
Outcome measures
| Measure |
DEX (Dexamethasone)
n=18 Participants
Participants in this arm received dexamethasone (Decadron) 8 mg oral daily following chemotherapy cycle 1 or 2, on days 2-4 after HEC (or days 2-3 after MEC).
|
OLA (Olanzapine)
n=18 Participants
Participants in this arm received olanzapine (Zyprexa) 10 mg oral each night following chemotherapy cycle 1 or 2, on days 1-4 after HEC (or days 1-3 after MEC).
|
|---|---|---|
|
Sedation (Medication Side Effect)
|
12 Participants
|
14 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 120 hours after chemotherapyPopulation: All participants who received intervention dose and responded to the post-treatment questionnaire. Not all patients responded to the survey questions so there were fewer responses collected than there were patients surveyed. Of the patients in Arm A (DEX), 18 responded to the survey questions and in Arm B (OLA), 18 responded to the survey questions. Study was terminated without statistical analysis.
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.
Outcome measures
| Measure |
DEX (Dexamethasone)
n=18 Participants
Participants in this arm received dexamethasone (Decadron) 8 mg oral daily following chemotherapy cycle 1 or 2, on days 2-4 after HEC (or days 2-3 after MEC).
|
OLA (Olanzapine)
n=18 Participants
Participants in this arm received olanzapine (Zyprexa) 10 mg oral each night following chemotherapy cycle 1 or 2, on days 1-4 after HEC (or days 1-3 after MEC).
|
|---|---|---|
|
Insomnia (Medication Side Effect)
|
8 Participants
|
5 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 120 hours after chemotherapyPopulation: All participants who received intervention dose and responded to the post-treatment questionnaire. Not all patients responded to the survey questions so there were fewer responses collected than there were patients surveyed. Of the patients in Arm A (DEX), 18 responded to the survey questions and in Arm B (OLA), 18 responded to the survey questions. Study was terminated without statistical analysis.
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.
Outcome measures
| Measure |
DEX (Dexamethasone)
n=18 Participants
Participants in this arm received dexamethasone (Decadron) 8 mg oral daily following chemotherapy cycle 1 or 2, on days 2-4 after HEC (or days 2-3 after MEC).
|
OLA (Olanzapine)
n=18 Participants
Participants in this arm received olanzapine (Zyprexa) 10 mg oral each night following chemotherapy cycle 1 or 2, on days 1-4 after HEC (or days 1-3 after MEC).
|
|---|---|---|
|
Agitation (Medication Side Effect)
|
5 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 120 hours after chemotherapyPopulation: All participants who received intervention dose and responded to the post-treatment questionnaire. Not all patients responded to the survey questions so there were fewer responses collected than there were patients surveyed. Of the patients in Arm A (DEX), 18 responded to the survey questions and in Arm B (OLA), 18 responded to the survey questions. Study was terminated without statistical analysis.
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.
Outcome measures
| Measure |
DEX (Dexamethasone)
n=18 Participants
Participants in this arm received dexamethasone (Decadron) 8 mg oral daily following chemotherapy cycle 1 or 2, on days 2-4 after HEC (or days 2-3 after MEC).
|
OLA (Olanzapine)
n=18 Participants
Participants in this arm received olanzapine (Zyprexa) 10 mg oral each night following chemotherapy cycle 1 or 2, on days 1-4 after HEC (or days 1-3 after MEC).
|
|---|---|---|
|
Indigestion (Medication Side Effect)
|
8 Participants
|
8 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 120 hours after chemotherapyPopulation: All participants who received intervention dose and responded to the post-treatment questionnaire. Not all patients responded to the survey questions so there were fewer responses collected than there were patients surveyed. Of the patients in Arm A (DEX), 18 responded to the survey questions and in Arm B (OLA), 18 responded to the survey questions. Study was terminated without statistical analysis.
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.
Outcome measures
| Measure |
DEX (Dexamethasone)
n=18 Participants
Participants in this arm received dexamethasone (Decadron) 8 mg oral daily following chemotherapy cycle 1 or 2, on days 2-4 after HEC (or days 2-3 after MEC).
|
OLA (Olanzapine)
n=18 Participants
Participants in this arm received olanzapine (Zyprexa) 10 mg oral each night following chemotherapy cycle 1 or 2, on days 1-4 after HEC (or days 1-3 after MEC).
|
|---|---|---|
|
Depression (Medication Side Effect)
|
2 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 120 hours after chemotherapyPopulation: All participants who received intervention dose and responded to the post-treatment questionnaire. Not all patients responded to the survey questions so there were fewer responses collected than there were patients surveyed. Of the patients in Arm A (DEX), 18 responded to the survey questions and in Arm B (OLA), 18 responded to the survey questions. Study was terminated without statistical analysis.
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.
Outcome measures
| Measure |
DEX (Dexamethasone)
n=18 Participants
Participants in this arm received dexamethasone (Decadron) 8 mg oral daily following chemotherapy cycle 1 or 2, on days 2-4 after HEC (or days 2-3 after MEC).
|
OLA (Olanzapine)
n=18 Participants
Participants in this arm received olanzapine (Zyprexa) 10 mg oral each night following chemotherapy cycle 1 or 2, on days 1-4 after HEC (or days 1-3 after MEC).
|
|---|---|---|
|
Increased Appetite (Medication Side Effect)
|
9 Participants
|
8 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 120 hours after chemotherapyPopulation: All participants who received intervention dose and responded to the post-treatment questionnaire. Not all patients responded to the survey questions so there were fewer responses collected than there were patients surveyed. Of the patients in Arm A (DEX), 18 responded to the survey questions and in Arm B (OLA), 18 responded to the survey questions. Study was terminated without statistical analysis.
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.
Outcome measures
| Measure |
DEX (Dexamethasone)
n=18 Participants
Participants in this arm received dexamethasone (Decadron) 8 mg oral daily following chemotherapy cycle 1 or 2, on days 2-4 after HEC (or days 2-3 after MEC).
|
OLA (Olanzapine)
n=18 Participants
Participants in this arm received olanzapine (Zyprexa) 10 mg oral each night following chemotherapy cycle 1 or 2, on days 1-4 after HEC (or days 1-3 after MEC).
|
|---|---|---|
|
Decreased Appetite (Medication Side Effect)
|
5 Participants
|
6 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 120 hours after chemotherapyPopulation: All participants who received intervention dose and responded to the post-treatment questionnaire. Not all patients responded to the survey questions so there were fewer responses collected than there were patients surveyed. Of the patients in Arm A (DEX), 18 responded to the survey questions and in Arm B (OLA), 18 responded to the survey questions. Study was terminated without statistical analysis.
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.
Outcome measures
| Measure |
DEX (Dexamethasone)
n=18 Participants
Participants in this arm received dexamethasone (Decadron) 8 mg oral daily following chemotherapy cycle 1 or 2, on days 2-4 after HEC (or days 2-3 after MEC).
|
OLA (Olanzapine)
n=18 Participants
Participants in this arm received olanzapine (Zyprexa) 10 mg oral each night following chemotherapy cycle 1 or 2, on days 1-4 after HEC (or days 1-3 after MEC).
|
|---|---|---|
|
Rash (Medication Side Effect)
|
3 Participants
|
2 Participants
|
Adverse Events
DEX (Dexamethasone)
OLA (Olanzapine)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DEX (Dexamethasone)
n=23 participants at risk
Participants in this arm received dexamethasone (Decadron) 8 mg oral daily following chemotherapy cycle 1 or 2, on days 2-4 after HEC (or days 2-3 after MEC).
|
OLA (Olanzapine)
n=23 participants at risk
Participants in this arm received olanzapine (Zyprexa) 10 mg oral each night following chemotherapy cycle 1 or 2, on days 1-4 after HEC (or days 1-3 after MEC).
|
|---|---|---|
|
Investigations
Adverse event resulting in elimination from study eligibility
|
4.3%
1/23 • Through study completion, an average of 30 days.
Adverse events follow the guidelines of ClinicalTrials.gov definitions
|
0.00%
0/23 • Through study completion, an average of 30 days.
Adverse events follow the guidelines of ClinicalTrials.gov definitions
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place