Chemotherapy-induced Nausea and Vomiting
Conditions
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.
Detailed 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.
Interventions
DRUGOLA 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).
DRUGDEX 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).
Sponsors
The Guthrie Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
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 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Complete Response (CR) Over 120 Hours Following Chemotherapy | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Complete Control (CC) Over 120 Hours Following Chemotherapy | 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. |
| Number of Patients With Total Control (TC) Over 120 Hours Following Chemotherapy | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORZane Waite, PharmD, BCOP
The Guthrie Clinic
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 22 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 23 |
| other Total, other adverse events | 1 / 23 | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 | 0 / 23 |
Outcome results
None listed