Netupitant/Palonosetron Hydrochloride and Dexamethasone With or Without Prochlorperazine or Olanzapine in Improving Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer
Breast Carcinoma
About this trial
This is an interventional supportive care trial for Breast Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Have a diagnosis of breast cancer and be chemotherapy naive; NOTE: prior methotrexate for non-cancerous conditions is allowed
- Be scheduled to receive a single-day chemotherapy regimen that contains doxorubicin and/or cyclophosphamide and/or carboplatin; 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 clinical evidence of current or impending bowel obstruction
- 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
- CYCLE II PORTION ONLY: Must still meet all the exclusion criteria for cycle 1
Sites / Locations
- Hawaii MU NCORPRecruiting
- Decatur Memorial HospitalRecruiting
- Gulf South MU-NCORPRecruiting
- Michigan Cancer Research ConsortiumRecruiting
- Cancer Research Consortium of West MichiganRecruiting
- Health Partners IncRecruiting
- Cancer Research for the Ozarks NCORPRecruiting
- Nevada Cancer Research Foundation NCORPRecruiting
- University of Rochester NCORP Research Base
- Southeast Clinical Oncology Research ProgramRecruiting
- Columbus NCORPRecruiting
- Dayton Clinical Oncology ProgramRecruiting
- Geisinger Cancer Institute NCORPRecruiting
- Greenville NCORPRecruiting
- Upstate Carolina NCORPRecruiting
- Saint Vincent Hospital Cancer Center Green BayRecruiting
- Gundersen Health SystemRecruiting
- Aurora NCORPRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Group I (netupitant/palonosetron hydrochloride, dexamethasone
Group II (net/pal hydro, dexa, prochlorperazine, placebo)
Group III (net/pal hydro, dexa, olanzapine, placebo)
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.
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.
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.