UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy of combination antiemetic therapy with Olanzapine, Palonosetron and dexamethasone for the prevention of nausea and vomiting in patients receiving Moderately Emetogenic Chemotherapy
Acronym	The efficacy of Olanzapine for MEC
Scientific Title	The efficacy of combination antiemetic therapy with Olanzapine, Palonosetron and dexamethasone for the prevention of nausea and vomiting in patients receiving Moderately Emetogenic Chemotherapy
Scientific Title:Acronym	The efficacy of Olanzapine for MEC
Region	Japan

Condition
Condition	gastric cancer, colorectal cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of combination antiemetic therapy with Olanzapine, Palonosetron and dexamethasone for the prevention of nausea and vomiting in patients receiving moderately emetogenic chemotherapy(e.g. oxaliplatin)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	Complete response rate for the overall phase(0-120 hours), defined as no emetic episodes and no use of rescue medication
Key secondary outcomes	"Complete response rate for the acute phase(0-24 hours), Complete response rate for the delayed phase(24-120 hours), Complete control rate for the acute, delayed and overall phase, Total control rate for the acute, delayed and overall phase, Degrees of nausea, appetite, Fatigue, hiccup and sleepiness, Number of vomiting, Presence or absence of use of olanzapine after the third course, Presence or absence of reduction of chemotherapy after the second course Frequency /severity of adverse events "

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Palonosetron, dexamethasone, olanzapine
Interventions/Control_2	Palonosetron, dexamethasone
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	"Patinets with Gastrointestinal cancer who had not received moderately emetogenic chemotherapy regimen:XELOX, SOX European Cooperative Oncology Group(ECOG) performance status of 0,1,2 Adequate organ function Within 8 days before registration as follows; AST<100 IU/L,ALT<100 IU/L,Serum bilirubin<2.0mg/dL,Creatinine clearance>60 mL/min Written informed consent from patinets Regimen including palonosetron and dexamethasone Patients who can understand and write the diary"
Key exclusion criteria	"A history of allergy to drugs and similar compounds used in this study Patients who do not have general condition that can endure chemotherapy History of symptomatic brain metastasis or gastrointestinal obstruction nausea and vomiting within 24 hours before chemotherapy A history of diabetes, or HbA1c(NGSP)>6.5% or HbA1c(JDS)>6.1 %"
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Kazuhide Middle name Last name Higuchi
Organization	Osaka Medical College
Division name	Gastroenterology
Zip code	5698686
Address	2-7 Daigaku-machi, Takatsuki City, Osaka, Japan
TEL	072-683-1211
Email	higuchi@osaka-med.ac.jp

Public contact
Name of contact person	1st name Masahiro Middle name Last name Goto
Organization	Osaka Medical College Hospital
Division name	Chemotherapy Center
Zip code	5698686
Address	2-7 Daigaku-machi, Takatsuki City, Osaka, Japan
TEL	072-683-1211
Homepage URL
Email	in2030@osaka-med.ac.jp

Sponsor
Institute	Osaka Medical Collage
Institute
Department

Funding Source
Organization	Osaka Medical Collage
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	Osaka Medical Collage Chemotherapy Center
Address	2-7 Daigaku-machi, Takatsuki City, Osaka, Japan
Tel	0726831211
Email	ctc012@osaka-med.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	大阪医科大学附属病院、洛和会音羽病院消化器内科、北摂総合病院、市立ひらかた病院

Other administrative information
Date of disclosure of the study information	2018 Year 10 Month 04 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
Results
Results date posted
Results Delayed
Results Delay Reason
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	Terminated
Date of protocol fixation	2018 Year 11 Month 01 Day
Date of IRB	2019 Year 02 Month 19 Day
Anticipated trial start date	2018 Year 11 Month 01 Day
Last follow-up date	2021 Year 07 Month 10 Day
Date of closure to data entry	2022 Year 10 Month 07 Day
Date trial data considered complete	2022 Year 10 Month 07 Day
Date analysis concluded	2022 Year 10 Month 07 Day

Other
Other related information

Management information
Registered date	2018 Year 10 Month 04 Day
Last modified on	2022 Year 10 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039198