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Study stopped due to lower than expected accrual.
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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.
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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OLA then crossover to DEX | Experimental | OLA group: olanzapine (Zyprexa) 10 mg oral each night after chemotherapy cycle 1 on days 1-4 after HEC (or days 1-3 after MEC). DEX group: dexamethasone (Decadron) 8 mg oral daily after chemotherapy cycle 2 on days 2-4 after HEC (or days 2-3 after MEC) |
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| DEX then crossover to OLA | Active Comparator | DEX group: dexamethasone (Decadron) 8 mg oral daily after chemotherapy cycle 1 on days 2-4 after HEC (or days 2-3 after MEC) OLA group: olanzapine (Zyprexa) 10 mg oral each night after chemotherapy cycle 2 on days 1-4 after HEC (or days 1-3 after MEC). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Total Control (TC- no emesis, no rescue medication, no nausea) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zane Waite, PharmD, BCOP | The Guthrie Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Packer Hospital | Sayre | Pennsylvania | 18840 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 29, 2026 | Jun 24, 2026 | 7 | ||
| Jul 7, 2026 |
| ID | Term |
|---|---|
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 after HEC (days 2-3 after MEC).
OLA group: olanzapine (Zyprexa)10 mg oral each night on days 1-4 after HEC (days 2-3 after MEC).
For the second cycle of chemotherapy, the subject will switch to the other group.
Groups:
OLA then DEX; DEX then OLA
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| 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). |
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no emesis, no rescue medication, no nausea
| 120 hours following chemotherapy |
| Severity of nausea and vomiting self-reported by patient questionnaire | None, mild or greater than mild | 120 hours after chemotherapy |
| medication side effects | medication side effects including sedation, insomnia, agitation, indigestion/heartburn, depression, anorexia, increased appetite/hunger and rash/acne | 120 hours after chemotherapy |