Treatment of Refractory Nausea and Vomiting in Patients With Breast Cancer
NCT ID: NCT03367572
Last Updated: 2025-09-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1363 participants
INTERVENTIONAL
2018-04-19
2024-04-13
Brief Summary
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Detailed Description
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I. To determine if control of nausea at cycle 2 in participants who experienced chemotherapy-induced nausea and vomiting (CINV) at cycle 1 is improved by the addition of either prochlorperazine or olanzapine to the control arm of netupitant, palonosetron and dexamethasone.
SECONDARY OBJECTIVES:
I. To determine if olanzapine is more effective than prochlorperazine in controlling nausea at cycle 2 in participants who experienced CINV at cycle 1 when used in combination with netupitant, palonosetron and dexamethasone.
II. To determine if control of vomiting at cycle 2 in patients who experienced CINV at cycle 1 is improved by the addition of either prochlorperazine or olanzapine to the control arm of netupitant, palonosetron and dexamethasone.
III. To determine if olanzapine is more effective than prochlorperazine in controlling vomiting at cycle 2 in participants who experienced CINV at cycle 1 when used in combination with netupitant, palonosetron and dexamethasone.
TERTIARY OBJECTIVES:
I. To create an empirically-based algorithm predicting nausea from breast cancer chemotherapy regimens that takes into account not only state-of-the-art anti-emetic regimens but also participant factors such as age, race, education, ethnicity, quality of life (QOL), alcohol consumption, susceptibility to nausea, expectancy, anxiety, level of nausea on the day prior to treatment, and prior history of nausea.
II. To compare the effects of the interventions on QOL, as assessed by the Functional Assessment of Cancer Therapy- General (FACT-G), by following the same procedures described under the primary aim and the first secondary aim, using change in the FACT-G scores as the response.
III. To provide preliminary data on the frequency and severity of sleep disturbance, fatigue, anxiety, and dizziness, across treatment conditions.
IV. To provide preliminary data on biological factors (e.g. glutathione \[GSH\] recycling, genetic markers) that may help identify a subgroup of patients at high risk for development of cancer-related or treatment-related side effects, or response to treatment.
OUTLINE:
PART I: Patients receive 1 cycle of standard of care chemotherapy.
PART II: Patients with a nausea score \>= 3 at least once on the diary at cycle 1 chemotherapy are randomized into 1 of 3 groups at cycle 2.
GROUP I: Within 1 hour prior to chemotherapy, patients receive netupitant/palonosetron hydrochloride orally (PO) on day 1. Within 30 minutes prior to chemotherapy, patients also receive dexamethasone PO on days 1-4. Patients also receive placebo PO with chemotherapy every 8 hours (Q8H) on days 1-4.
GROUP II: Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive prochlorperazine PO Q8H and placebo PO with chemotherapy on days 1-4.
GROUP III: Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive olanzapine PO and placebo PO Q8H with chemotherapy on days 1-4.
After completion of study treatment, patients are followed up for 30 days.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Group I (netupitant/palonosetron hydrochloride, dexamethasone
Within 1 hour prior to chemotherapy, patients receive netupitant/palonosetron hydrochloride PO on day 1. Within 30 minutes prior to chemotherapy, patients also receive dexamethasone PO on days 1-4. Patients also receive placebo PO with chemotherapy Q8H on days 1-4.
Dexamethasone
Given PO
Laboratory Biomarker Analysis
Correlative studies
Netupitant/Palonosetron Hydrochloride
Given PO
Placebo
Given PO
Quality-of-Life Assessment
Ancillary studies
Group II (net/pal hydro, dexa, prochlorperazine, placebo)
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive prochlorperazine PO Q8H and placebo PO with chemotherapy on days 1-4.
Dexamethasone
Given PO
Laboratory Biomarker Analysis
Correlative studies
Netupitant/Palonosetron Hydrochloride
Given PO
Placebo
Given PO
Prochlorperazine
Given PO
Quality-of-Life Assessment
Ancillary studies
Group III (net/pal hydro, dexa, olanzapine, placebo)
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive olanzapine PO and placebo PO Q8H with chemotherapy on days 1-4.
Dexamethasone
Given PO
Laboratory Biomarker Analysis
Correlative studies
Netupitant/Palonosetron Hydrochloride
Given PO
Olanzapine
Given PO
Placebo
Given PO
Quality-of-Life Assessment
Ancillary studies
Interventions
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Dexamethasone
Given PO
Laboratory Biomarker Analysis
Correlative studies
Netupitant/Palonosetron Hydrochloride
Given PO
Olanzapine
Given PO
Placebo
Given PO
Prochlorperazine
Given PO
Quality-of-Life Assessment
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Be scheduled to receive a single-day chemotherapy regimen that contains doxorubicin and/or cyclophosphamide and/or carboplatin. Single-day chemotherapy is defined as only one infusion or injection per cycle. Herceptin (trastuzumab) and other chemotherapy agents will be allowed with any of these regimens
* Be scheduled to receive an antiemetic regimen that does not contain Akynzeo; in addition, the antiemetic regimen must conform with American Society of Clinical Oncology (ASCO) Clinical Practice Guidelines at cycle 1
* Be able to read English
* Have the ability to give written informed consent
* Have Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* NOTE: patients 80 years of age or older must have approval from an oncologist or their designee to participate in this study
* NOTE: patients currently receiving warfarin must have approval from an oncologist or their designee to participate in this study
* Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, or abstinence) for the duration of the study and have a negative pregnancy test within 10 days prior to the initiation of chemotherapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
* CYCLE II PORTION ONLY: Only participants with a nausea score \>= 3 at least once on the diary assessment from cycle 1 can be randomized for cycle 2
* CYCLE II PORTION ONLY: Participants must be scheduled to receive the same chemotherapy regimen as received at cycle 1
Exclusion Criteria
* Have a known history of central nervous system disease (e.g., brain metastases or a seizure disorder)
* Have dementia
* Have uncontrolled diabetes mellitus or uncontrolled hyperglycemia
* Have severe hepatic impairment, severe renal impairment, or end-stage renal disease as determined by the treating physician
* Have had long term treatment (\> 5 days within the past 30 days) with an antipsychotic agent such as risperidone, quetiapine, clozapine, a phenothiazine, or a butyrophenone within 30 days before enrollment or plans for such treatment during the study period; NOTE: participants could have received prochlorperazine and other phenothiazines as antiemetic therapy on a short term basis (i.e., =\< 5 days)
* Have a known cardiac arrhythmia, uncontrolled congestive heart failure, or acute myocardial infarction within the previous 6 months
* Be taking benzodiazepines regularly (\> 5 days within the past 30 days); pro re nata (PRN) use (=\< 5 days) for the short-term relief of the symptoms of anxiety, anxiety associated with depressive symptoms, or as a rescue medication for breakthrough CINV is allowed
* Be taking anticholinergic medications
* Be receiving quinolone antibiotic therapy
* Be taking amifostine (Ethiofos)
* Have a known hypersensitivity to olanzapine or to phenothiazines
* CYCLE II PORTION ONLY: Must not have received Akynzeo at cycle 1
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Rochester NCORP Research Base
OTHER
Responsible Party
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Luke Peppone
Associate Professor of Surgery and Orthopaedics
Principal Investigators
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Luke Peppone
Role: PRINCIPAL_INVESTIGATOR
University of Rochester NCORP Research Base
Locations
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Hawaii MU NCORP
Honolulu, Hawaii, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Gulf South MU-NCORP
New Orleans, Louisiana, United States
Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
Cancer Research Consortium of West Michigan
Grand Rapids, Michigan, United States
Health Partners Inc
Minneapolis, Minnesota, United States
Cancer Research for the Ozarks NCORP
Springfield, Missouri, United States
Nevada Cancer Research Foundation NCORP
Las Vegas, Nevada, United States
University of Rochester NCORP Research Base
Rochester, New York, United States
Southeast Clinical Oncology Research Program
Winston-Salem, North Carolina, United States
Columbus NCORP
Columbus, Ohio, United States
Dayton Clinical Oncology Program
Dayton, Ohio, United States
Geisinger Cancer Institute NCORP
Danville, Pennsylvania, United States
Greenville NCORP
Greenville, South Carolina, United States
Upstate Carolina NCORP
Spartanburg, South Carolina, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States
Gundersen Health System
La Crosse, Wisconsin, United States
Aurora NCORP
Milwaukee, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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NCI-2017-00902
Identifier Type: REGISTRY
Identifier Source: secondary_id
URCC16070
Identifier Type: OTHER
Identifier Source: secondary_id
URCC-16070
Identifier Type: OTHER
Identifier Source: secondary_id
URCC16070
Identifier Type: -
Identifier Source: org_study_id
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