Randomized study of prochlorperazine for the prophylaxis of oxycodon induced nausea in patients with cancer related pai
- Conditions
- advanced cancer
- Registration Number
- JPRN-UMIN000012008
- Lead Sponsor
- on-Profit Organization JORTC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Not provided
1) Patients in need of anti-emesis medication (roughly >= NRS 3) Anti-emesis medication: prochlorperazine, metoclopramide, itopride, Mosapride citrate hydrate, Sulpiride, steroid 2) Episode of vomiting within 48hrs before registration 3) Patients with dementia, delirium, depressed level of consciousness, communication disorder due to aphasia, dyslexia, dysarthria etc 4) Patients with severe infection 5) Hypercalcemia (adjusted Ca conc (Ca mg/dL +(4-Alb)>11mg/dL) 6) Patient with ileus 7) Symptomatic brain metastasis 8) Patients who are planned to start chemotherapy or radiation therapy in purpose for palliation cancer pain, before the improvement of cancer pain by this protocol treatment. 9) Comorbidity which treatments take priority over cancer treatment. 10) Increase, decrease, cessation of hyptonic, anti-anxiety agent (tricyclic or tetracyclic, anti depressant, SNRI, SSRI, etc), psychotropic agent, anticonvulsant agent, ketamine hydrochloride) within 24hrs before registration 11) Patients taking adrenalin 12) Patients who are suspicious of sub-cortex brain disorder 13) Patients taking anticholinergic agent, triazole antifungal antibiotics 14) Patient who were judged to be ineligible by the doctor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The worst value of nausea (evaluated by NRS 0-10 of MDASI) during the first 7 days after the start of protocol treatment.
- Secondary Outcome Measures
Name Time Method 1) Number of vomiting during the first 7 days after the start of protocol treatment. 2) Proportion of patients who could not continue taking oxycodone due to nausea 3) The worst value of pain, sleepness, malaise, sleep disorder, and loss of appetite (evalueted by NRS 0-10 of MDASI) during the first 7 days after the start of protocol treatment. 4) Proportion of patients using anti-emesis medication 5) Adverse events of prochlorperazine