breast cancer
Conditions
Interventions
Sponsors
Hoshi University Division of Applied Pharmaceutical
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with breast cancer 2) Patients who are over 20 years old at thetime of registration 3) The patients whom highly emetogenic chemotherapy for breast cancer is given in for the first time 4) Eastern Cooperative Oncology Group(ECOG) performance status(PS) of 0, 1 or 2 5) Patients who have adequate organ functions <Each of the following values are examined within 2 weeks before registration for this study> ALT < 100 U/L AST < 100 U/L T-Bil < 2.0 mg/dL CCr >= 55 mL/min 6) Patients who got written informed consent prior to registration
Exclusion criteria
Exclusion criteria: 1) Patients who has history of hypersensitivity or allergy for study drugs or similar compounds. 2) Patients taking systemic corticosteroid (oral and intravenous) except for inhaled or topical corticosteroid preparation 3) Patients having a clear vomiting symptom such as brain metastasis or gastrointestinal obstruction to the passage of foods 4) Patients with symptomatic ascites or pleural effusions requiring therapeutic puncture 5) Patients with obstruction of gastrointestinal tract, for example gastric outlet or ileus etc. 6) Patients who have convulsive disorders requiring anticonvulsants therapy 7) Patients receieving adrenaline or pimozide 8) Patients who start taking opioids within 48 h prior to registration 9) Patients who received radiation therapy to abdomen or pelvis within 6 days prior to registration or will receive radiation therapy until 6 days after cisplatin administration 10) Patients regularly taking antiemetics other than study drugs 11) Pregnant, breastfeeding or expecting women or who do not wish to use contraception 12) Patients with diabetes mellitus receiving treatment of antidiabetic agents or having HbA1c (NGSP) 6.5 or more, or HbA1c (NGSP) in less than 28 days before registration is the patient with (in the case of JDS more than 6.1%) 6.5% or more. 13) Patients with smoking habit 14) The patients who have difficulty in operation such as the input, and the like of EDC. 15) Patients who are judged to be inappropriate for the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Control in overall phase | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 TC ratio in acute and late phase 2 Complete response of all period and acute phase, late phase 3 Complete control of all periods and acute and late stages 4 No nausea for all period and acute phase, late phase 5 Time to treatment failure (TTF) 6 adverse events | — |
Countries
Japan
Contacts
Public ContactKenichi Suzuki
Hoshi University Division of Applied Pharmaceutical
Outcome results
None listed