Study of Palonosetron / Dexamethasone / Olanzapine for nausea and vomiting induced chemotherapy for breast cancer

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2012
INTERVENTION: We use three anti emesis drugs (Palonosetron/Dexamethasone/Olanzapine) for this trial. The treatment schedule of 1) Palonosetron is intravenous administrated slowly 30 seconds or more for 0.75mg before administration of chemotherapy. 2) Dexamethasone is intravenous administrated 13.2mg‐16.5mg before administration of chomothetrapy. And oral administrated 4mg at after breakfast and dinner on day 2‐5. 3) Olanzapine is oral administrated 5mg before dinner or retiring. CONDITION: Breast cancer PRIMARY OUTCOME: The proportion of patients with no emetic episodes and no rescue medication (Complete Response(CR)) for 5 days SECONDARY OUTCOME: Complete Control (CC) rate: defined as no emetic episodes, no rescue medication use, and no more than mild nausea for 5 days.; Time to Treatment Failure: time to first emetic episode or time to administration of rescue therapy, whichever occurred first INCLUSION CRITERIA: 1) Histological confirmation of breast Cancer. 2) age 20 years or more patients. 3) The following treatment is planned. A) Cyclophosphamide >= 500mg/m2 B) Doxorubicin >= 50mg/m2 C) Epirubicin >= 60mg/m2 4) adequate organ function, defined as WBC >= 3000/mm3 and/or Neu >= 1500/mm3 ,AST < 5.0xULN IU/L, ALT < 5.0xULN IU/L 5) performance status (PS) 0‐2 6) written informed consent from the patients.
Epistemonikos ID: 944dc447e8fb311661153ff0f70195e7e7822c4e
First added on: Aug 22, 2024