Study of Palonosetron / Dexamethasone / Olanzapine for nausea and vomiting induced chemotherapy for breast cancer.
- Conditions
- Breast cancer
- Registration Number
- JPRN-UMIN000008064
- Lead Sponsor
- Saitama Breast Cancer Clinical Study Group (SBCCSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 55
Not provided
The exclusion criteria were as follows; patients were not eligible for this study if 1)they were Advanced or Recurrent breast Cancer patients. 2) they had child-pugh score > 9 3) they had undergone treatment with high emetic risk and moderate emetic risk chemotherapy by Japan society of clinical oncology prior to this study 4) they had undergone treatment with clarithromycin, ketoconazole, itraconazole within 7 days. 5) they had undergone treatment with barbiturate, rifampicin, phenytoin, carbamazepine within 4 weeks. 6) they took warfarin. 7) they took oral contraceptive. 8) they had deep venous thrombosis 9) they had ascites or pleural effusion needs paracentesis treatment. 10) they had serious complication. (intestinal paralysis, lung fibrosis, diabetes mellitus, heart failure, myocardial infarction, angina pectoris, renal failure, psychiatric disorder, cerebrovascular accident, active gastric ulcer, active duodenal ulcer. 11) they had diabetes mellitus or past history of diabetes mellitus. 12) they had an associated symptom (ex infectious disease) patient who can not administer dexamethasone for 5 days. 13) they had a brain metastasis or suspected case. 14) they had hypersensitivity for Palonosetron or Dexamethason or Olanzapine. 15) they operated radiation therapy 16) they except referred to above, physician in charge of this trial gave a diagnosis the patient who can not joint this trail for the safety.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of patients with no emetic episodes and no rescue medication (Complete Response(CR)) for 5 days
- Secondary Outcome Measures
Name Time Method 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