Efficacy of olanzapine for relief of nausea with incomplete bowel obstruction in advanced cancer patient: pragmatic randomized controlled trial
- Conditions
- ausea with incomplete bowel obstruction
- Registration Number
- JPRN-UMIN000010317
- 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
- 40
Not provided
1) Patients received chemotherapy or radiation therapy within 28 days 2) Patients diagnosed diabetes mellitus or having history of diabetes mellitus (possibility of worsening diabetes mellitus) Diagnosis of diabetes mellitus is on the basis of 1. fasting blood sugar >=126 mg/dl, 2. 2-hour blood sugar level after 75g glucose tolerance test >=200 mg/dl or 3. random blood sugar >=200 mg/dl and HbA1c >=6.5% 3) Patients administrated with dopaminergic drugs such as phenothiazine, butyrophenone and atypical antipsychotic within 3 days 4) Patients with nasogastric tube, percutaneous endoscopic gastrostomy and percutaneous trans-esophageal gastro-tubing 5) Patients with indication of surgery or chemotherapy 6) Patients with bowel obstruction due to non malignant disease 7) Patients with complete bowel obstruction 8) Patients with signs of gastrointestinal tract perforation or sepsis 9) Patients with incidence of colic pain (paroxysmal and repetitive abdominal pain) within 48 hours 10) Patients with high risk of colic pain according to metoclopramide 11) Patients who are judged to be inappropriate for the study by the responsible researcher 12) Patients lacking in ability to make suitable decisions 13) Patients who are judged to be inappropriate for the study by the physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in the average value of nausea for 24 hours with Numeric Rating Scale (NRS)
- Secondary Outcome Measures
Name Time Method Proportion of patients with average value of nausea reduced more than 30% in NRS, number of vomit, satisfaction rating and intention to continue treatment