Thoracic malignancy
Conditions
Interventions
Aprepitant, palonosetron, dexamethasone and olanzapine
Sponsors
Shizuoka cancer center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Thoracic malignancy 2) ECOG PS 1 or 2 3) Aged 20 or more 4) Cisplatin-based chemotherapy naive 5) Adequate organ functions 6) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Prior severe hypersensitivity to aprepitant, 5HT3 receptor antagonist, corticosteroids or olanzapine 2) Patients who do not have enough whole body state to the antineoplastic agents treatment 3) Severe complication 4) Patients who have conceived child or desire childbearing or breast-feed their baby 5) Patients enforced radiotherapy at the bottom of diaphragm on the period between 6 days before and 6 days after of the date of first therapy 6) Patients who cannot stay in hospital till the 6th day of chemotherapy 7) HbA1c (NGSP) >= 6.5. FBS >= 126mg/dl or BS >= 200mg/dl 8) Diabetes mellitus 9) Patient with nausea and vomiting needing for medical treatment beore chemotherapy 10) Patient who have previous history or familial history of malignant syndrome 11) CK more than 2.5 times of institutional upper normal limit 12) Patients with active infection 13) Patient who cannot stop smoking during this study 14) BMI (body mass index) >= 35 15) Patients who take a medicine regularly ,for example , 5HT3 receptor antagonists, corticosteroids, antidopamine agonists, phenothiazine tranquilizers,antihistamine drugs, benzodiazepine,agents, etc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of patients with complete response (no emetic episodes and no use of rescue medication) for the overall period (0-120h post-administration of cisplatin) | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) The percentage of patients with complete response for the acute period (0-24h post-administration of cisplatin) and the delayed period (24-120h post-administration of cisplatin) (2) The percentage of patients with complete control (no emetic episodes, no use of rescue medication, and no more than mild nausea) for the acute period, the delayed period, and the overall period (3) The percentage of patients with total control (no emetic episodes, no use of rescue medication, and no nausea) for the acute period, the delayed period, and the overall period (4) Adverse events | — |
Countries
Japan
Contacts
Public ContactKazuhisa Nakashima
Shizuoka cancer center Division of Thoracic Oncology
Outcome results
None listed