UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043188 |
|---|---|
| Receipt number | R000049292 |
| Scientific Title | Non-randomized prospective study to verify the usefulness and safety of olanzapine as an antiemetic in transcatheter arterial chemoembolization for hepatocellular carcinoma. |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2024/02/12 13:10:51 |
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Basic information
Public title
Non-randomized prospective study to verify the usefulness and safety of olanzapine as an antiemetic in transcatheter arterial chemoembolization for hepatocellular carcinoma.
Acronym
Non-randomized prospective study to verify the usefulness and safety of olanzapine as an antiemetic in transcatheter arterial chemoembolization for hepatocellular carcinoma.
Scientific Title
Non-randomized prospective study to verify the usefulness and safety of olanzapine as an antiemetic in transcatheter arterial chemoembolization for hepatocellular carcinoma.
Scientific Title:Acronym
Non-randomized prospective study to verify the usefulness and safety of olanzapine as an antiemetic in transcatheter arterial chemoembolization for hepatocellular carcinoma.
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Targeting patients undergoing transcatheter arterial chemoembolization for hepatocellular carcinoma, we will verify the additional antiemetic effect and safety by using olanzapine in addition to the conventional antiemetics.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Achievement rate of complete response (CR) in the late stage (24 to 120 hours after treatment)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1. At the time of initial treatment
1) Dosing antiemetics (5-HT3 receptor antagonists, NK1 receptor antagonists, steroids) using conventional regimens.
Intravenous infusion of paloxenone 0.75 mg before treatment.
Intravenous infusion of aprepitant 150 mg before treatment
Intravenous infusion of dexamethasone 1.65 mg on day 1-4
2) In addition to the above 3 drugs, take olanzapine 5 mg on the day before treatment and before sleep on day 1-4.
2. At the time of the second treatment
1) Administer antiemetics using a regimen that uses three conventional drugs (5-HT3 receptor antagonist, NK1 receptor antagonist, and steroid).
2) Do not take olanzapine for comparison with the initial treatment.
Interventions/Control_2
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
Patients with hepatocellular carcinoma with a tumor diameter of 30 mm or more, or more than 2-3 who are recommended for transcatheter arterial chemoembolization as a treatment algorithm for hepatocellular carcinoma.
Key exclusion criteria
Those who fall under any of the following are excluded.
1) Patients who received other treatments up to 2 weeks before treatment with transcatheter arterial chemoembolization
2) Patients who have added other treatments such as surgery and radiofrequency ablation immediately after transcatheter arterial chemoembolization
3) Patients with marked decrease in hepatic reserve in Child Pugh classification C
4) Patients with symptomatological brain metastasis / cancerous meningitis
5) Patients who regularly use other antiemetics and antipsychotics
6) Patients with contraindicated items for olanzapine administration (mass ascites, intestinal obstruction, diabetes)
7) Other patients that the research doctor deems inappropriate
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kyoko |
| Middle name | |
| Last name | Oura |
Organization
Kagawa University Faculty of Medicine/Graduate School of Medicine
Division name
Department of Gastroenterology and Neurology
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan
TEL
087-891-5111
kyoko_oura@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Kyoko |
| Middle name | |
| Last name | Oura |
Organization
Kagawa University Faculty of Medicine/Graduate School of Medicine
Division name
Department of Gastroenterology and Neurology
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan
TEL
087-891-5111
Homepage URL
kyoko_oura@med.kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University
Institute
Department
Personal name
Funding Source
Organization
Kagawa University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagawa University Hospital Clinical Research Support Center
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan
Tel
0878985111
chiken@med.kagawa-u.ac.jp
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
| 2021 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
68
Results
For TACE-induced nausea and vomiting, the olanzapine group had similar complete response (CR) and complete control (CC) rates at 12 hours post-TACE as the control group but significantly higher CR and CC rates during the delayed phase after 24 hours and better patient satisfaction scores.
Results date posted
| 2024 | Year | 02 | Month | 12 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Due to not reaching the planned number of cases
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2021 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 30 | Day |
Last modified on
| 2024 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049292
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