advanced cancer
Conditions
Interventions
Combination group Oxycontine 5mgq12hr in combination with prochlorperazine maleate 5mg t.i.d.
Standard group Oxycontine 5mgq12hr after the emergence of nausea, prochlorperazine maleate 5mg
Sponsors
Non-Profit Organization JORTC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Agreement by patients to participate in this study. 2) Histologically or cytologically confirmed cancer. 3) ECOG performance status 0-3. 4) More than 7 days lapse after chemotherapy or radiation therapy. 5) Patient to start the opioid treatment (morphine, oxycodone, fentanyl) for the treatment of cancer pain and start periodic use of oxycodone 5mg bid (As needed use of potent opioid is permitted). 6) 20 years old or older. 7) Patient who can safely take oral mediation. 8) Expected survival of >= 4 weeks. 9) Patient who can keep a patient diary. 10) Patient has the following blood chemistry levels at baseline: AST (SGOT) <= 100IU/L ALT (SGPT) <= 100 IU/L TB <= 2.25 mg/dL creatinine <= 2.0 mg/dL.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The worst value of nausea (evaluated by NRS 0-10 of MDASI) during the first 7 days after the start of protocol treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactYasushi Goto
National Cancer Center Hospital Department of Thoracic Oncology
Outcome results
None listed