Malignant tumor (lung cancer, gynecological cancer, etc)
Conditions
Interventions
olanzapine 5mg orally every 24 hour for 72 hours for the treatment of breakthrough nausea and vomiting induced by chemotherapy.
Sponsors
Aichi Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Malignant tumor patients except for hematopoietic malignancy. (2) ECOG performance status 0-2. (3) 20 years-old over at the time of giving informed consent (4) Patients who have not had medical history of moderately and/or highly emetogenic chemotherapy regimen (5) CBDCA dose is AUC 5 or more. (6) Adequate organ function as defined by; AST and ALT < 5 x normal range, T-Bill <= 2.0 mg/dL. (Each of values are examined within 8days before prior to entry) (7) Oral ingestion is possible (8) Patient who got written consent from participation before registration
Exclusion criteria
Exclusion criteria: (1) Patients who has history of hypersensitivity or allergy for study drugs or similar compounds. (2) Patients who do not have enough whole body state to the antineoplastic agents treatment (3) Patient undergoing diabetes treatment (4) Patients with symptomatic brain metastasis (5) Patients who has a convulsive disorders that need anticonvulsants therapy. (6) Patients with symptomatic ascites that need therapeutic drainage. (7) Pregnant, breastfeeding or expecting woman, or patients without intention to contraception (8) Patients enforced radiotherapy on the period between 6 days before and 6 days after of the date of first therapy. (9) Patients who are using prophylactic antiemetic therapy drugs other than NK1 receptor antagonist, 5HT3 antagonist or dexamethasone. (10) Patients who take a medicine regularly antidopamine agonists, phenothiazine tranquilizers,antihistamine drugs, benzodiazepine,agents. (11) Judged by the investigator to be inappropriate for this study (12) Patients who has nausea at the start of chemotherapy (13) Patients who started opioids within 1 week of chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response (no emesis, no rescue medication) rate during 72 hours after administration of olanzapine. | — |
Secondary
| Measure | Time frame |
|---|---|
| The change of difference and percentage for nausea intensity (scale, 0-10) at 30, 60, 120 min and 24 hour after administration of olanzapine, and the degree of nausea relief (scale, 1-5) at 24 hour. Adverse event. | — |
Countries
Japan
Contacts
Public ContactAkimitsu Maeda
Aichi Cancer Center Hospital Department of pharmacy
Outcome results
None listed