Opioid-induced nausea and vomiting (OINV)
Conditions
Interventions
Dexamethasone
Sponsors
Teikyo University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or clinically confirmed malignant disease 2) Age >= 20 years 3) Planned regular doses of morphine, oxycodone, hydromorphone, codeine or tramadol >= 15mg/day MEDD 4) No prior opioid use within 21 days 5) No prior systemic steroid >5 mg PSL equivalent within 7 days 6) No nausea or vomiting within 7 days 7) No regular use of antiemetics, peristaltic enhancer or antipsychotics 8) Laboratory tests within 14 days meet criteria 9) Orally ingestible 10) Clear consciousness 11) Ability to fill out patient diary 12) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Brain metastasis with edema or meningeal carcinomatosis 2) Peritoneal dissemination, intestinal obstruction or intestinal stenosis with intestinal dilation 3) Constipation >= Grade 3 4) History of diabetes requiring medication 5) Administration of antineoplastic agents with high or moderate emetic risk within 21 days 6) Administration of antineoplastic agents with low emetic risk within 7 days 7) Abdominal surgery within 21 days 8) Infection requiring systemic treatment 9) Active peptic ulcer 10) History of HBV infection 11) Delirium within 1 year 12) History of steroid psychosis 13) Allergy to dexamethasone 14) Other conditions inappropriate for participating in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate at 72 hour after initiation of opioids | — |
Countries
Japan
Contacts
Public ContactYusuke Takagi
Teikyo University School of Medicine Dpt. Palliative Medicine
Outcome results
None listed