UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of olanzapine for relief of nausea with incomplete bowel obstruction in advanced cancer patient: pragmatic randomized controlled trial
Title of the study (Brief title)	Olanzapine for nausea with incomplete bowel obstruction
Region	Japan

Condition
Condition	Nausea with incomplete bowel obstruction
Classification by specialty	Medicine in general Hematology and clinical oncology Surgery in general
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To confirm the efficacy of olanzapine for relief of nausea with incomplete bowel obstruction in advanced cancer patient
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	Changes in the average value of nausea for 24 hours with Numeric Rating Scale (NRS)
Key secondary outcomes	Proportion of patients with average value of nausea reduced more than 30% in NRS, number of vomit, satisfaction rating and intention to continue treatment

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Group A: olanzapine (5 mg) Zydis or tablet 5mg/day (evening) orally
Interventions/Control_2	Group B: 1) metoclopramide (5 mg) tablet 30 mg/day (morning/noon/evening) orally or 2) metoclopramide (10 mg) injectable solution 20 mg/day (intermittent or continuous) subcutaneous or drip infusion
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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
Key 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
Target sample size	40

Research contact person
Name of lead principal investigator	Keisuke Kaneishi
Organization	Japan Community Health care Organization Tokyo Shinjuku Medical Center
Division name	Department of Palliative Care Unit
Address	5-1 Tsukudo-cho, Shinjuku-ku, Tokyo 162-8543, Japan
TEL	03-3269-8111
Email	kaneishi@tkn-hosp.gr.jp

Public contact
Name of contact person	Keisuke Kaneishi
Organization	Japan Community Health care Organization Tokyo Shinjuku Medical Center
Division name	Department of Palliative Care Unit
Address	5-1 Tsukudo-cho, Shinjuku-ku, Tokyo 162-8543, Japan
TEL	03-3269-8111
Homepage URL	http://www.jortc.jp/
Email	kaneishi@tkn-hosp.gr.jp

Sponsor
Institute	Non-Profit Organization JORTC
Institute
Department

Funding Source
Organization	Japanese Society for Palliative Medicine
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)	Japan Agency for Medical Research and Development

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2013 Year 03 Month 26 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 10 Month 03 Day
Anticipated trial start date	2013 Year 08 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 03 Month 26 Day
Last modified on	2018 Year 02 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012072