Breast Cancer
Conditions
Interventions
palonosetron + fosnetupitant + dexamethasone
Sponsors
Gifu University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Female patients with breast cancer. Patients scheduled to receive SG administration for the first time. Patients scheduled to start SG at the standard dose. Age >= 20 years at the time of enrollment. No use of the following concomitant medications within 48 hours prior to enrollment: Selective serotonin reuptake inhibitors (SSRI) Serotonin-norepinephrine reuptake inhibitors (SNRI) Serotonin-dopamine antagonists (SDA) Multi-acting receptor targeted antipsychotics (MARTA) NK1 receptor antagonists 5-HT3 receptor antagonists Corticosteroids (except topical use) Dopamine antagonists Phenothiazine-type tranquilizers Benzodiazepines (including thienodiazepines) Other centrally acting drugs Laboratory data within one month prior to enrollment meeting all of the following criteria: Total bilirubin <= 2.0 mg/dL AST <= 100 U/L ALT <= 100 U/L Written informed consent obtained from the patient.
Exclusion criteria
Exclusion criteria: Patients with a history of allergy to the study drugs or related compounds. Patients with diabetes mellitus receiving treatment with insulin or any oral hypoglycemic agents, as well as those with HbA1c (NGSP) >= 6.5% or HbA1c (JDS) >= 6.1% at enrollment. Patients for whom additional blood glucose monitoring (outside the scheduled tests) may lead to dose reduction or discontinuation of dexamethasone will also be excluded. Patients presenting with nausea or vomiting requiring antiemetic treatment at the time of enrollment. Patients who initiated opioid therapy (strong opioids) within 48 hours prior to enrollment. Patients with a history of any of the following within 6 months prior to enrollment: unstable angina, myocardial infarction, cerebral hemorrhage, cerebral infarction, or active gastric/duodenal ulcer. Patients with convulsive disorders requiring anticonvulsant therapy. Patients with ascites requiring therapeutic paracentesis. Patients with gastrointestinal obstruction, such as pyloric stenosis or ileus. Pregnant or lactating women, women who may be pregnant, or patients unwilling to use adequate contraception. Patients with psychiatric disorders or psychiatric symptoms that interfere with daily life and make participation in the study difficult. Any other patients deemed inappropriate for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response (no vomiting and no use of rescue medication) rate within 5 days (120 hours) from the start of the initial SG administration. | — |
Countries
Japan
Contacts
Public ContactAtsuko Tomida
Gifu University Hospital Department of Pharmacy
Outcome results
None listed