Malignant tumor (breast cancer, lung cancer, gastric cancer, esophagus cancer, colorectal cancer, etc)
Conditions
Interventions
Granisetron 3mg + dexamethasone (drip infusion)
Granisetron 1mg + dexamethasone (drip infusion)
Sponsors
Pharma Valley Center, Shizuoka Organization for Creation Industries
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Malignant tumor patients except for hematopoietic malignancy (2)20 years-old over (3)patients who receive the chemotherapy of the first course of each regimens (4)patients who use highly emetogenic antineoplastic agents more than moderate risk category <cf. ASCO clinical practice guideline,Recommendations for the use of Antiemetics> (5)patients who have adequate organ functions <Each of the following values are examined within 2weeks before registration for this study> 1)ALT <= 100 IU/L 2)AST <= 100 IU/L 3)T-Bil <= 2.0 mg/dL 4)CRE <= 1.5 mg/dL (6)Written informed consent
Exclusion criteria
Exclusion criteria: (1)patients with history of hypersensitivity to 5-HT3 receptor antagonist and corticosteroids (2)patient who do not have enough whole body state to the antineoplastic agents treatment (3)pregnant or expecting woman (4)patient who enforces radiotherapy in the abdomen on the day of chemotherapy (5)uncontrollable diabetes mellitus (6)hepatitis B or C virus Carrier (7)patients having a clear vomiting symptom such as brain metastasis or obstruction to the passage of foods (8)the patient who judged inappropriate as an object of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete protection from vomiting within 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Degree of nausea within 24 hours 2) Time to vomiting expression within 24 hours 3)The number of vomiting 4)Degree of nausea in the delayed phase 5)The change of the stool frequency | — |
Countries
Japan
Contacts
Public ContactTsuji Daiki
Seirei Hamamatsu General Hospital Department of Pharmacy Seirei Hamamatsu General Hospit
Outcome results
None listed