Nausea with incomplete bowel obstruction
Conditions
Interventions
Group A: olanzapine (5 mg) Zydis or tablet 5mg/day (evening) orally
Group B: 1) metoclopramide (5 mg) tablet 30 mg/day (morning/noon/evening) orally or 2) metoclopramide (10 mg) injectable solu
Sponsors
Non-Profit Organization JORTC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with metastatic or locally advanced cancer 2) Patients with incomplete bowel obstruction due to malignant tumor 3) Patients with NRS of nausea >=4 4) Patients with nausea not due to hypercalcemia, brain hypertension or drugs 5) Patients who can take oral medication 6) Patients aged 20 or above at the time of obtaining informed consent 7) Patients who agree to participate the study with written consent under a sufficient explanation and understanding 8) Hospitalized patients
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the average value of nausea for 24 hours with Numeric Rating Scale (NRS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with average value of nausea reduced more than 30% in NRS, number of vomit, satisfaction rating and intention to continue treatment | — |
Countries
Japan
Contacts
Public ContactKeisuke Kaneishi
Japan Community Health care Organization Tokyo Shinjuku Medical Center Department of Palliative Care Unit
Outcome results
None listed