UMIN-CTR Clinical Trial

Basic information
Public title	A phase II trial evaluating the effect of olanzapine 5mg for breakthrough nausea and vomiting in patients receiving carboplatin based chemotherapy
Acronym	The trial of olanzapine 5mg for breakthrough nausea and voimiting
Scientific Title	A phase II trial evaluating the effect of olanzapine 5mg for breakthrough nausea and vomiting in patients receiving carboplatin based chemotherapy
Scientific Title:Acronym	The trial of olanzapine 5mg for breakthrough nausea and voimiting
Region	Japan

Condition
Condition	Malignant tumor (lung cancer, gynecological cancer, etc)
Classification by specialty	Medicine in general Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of olanzapine 5mg orally every 24 hour for 72 hours for the breakthrough nausea and vomiting appeared within 120 hours after administration carboplatin-based moderate emetic chemotherapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Complete response (no emesis, no rescue medication) rate during 72 hours after administration of olanzapine.
Key secondary outcomes	The change of difference and percentage for nausea intensity (scale, 0-10) at 30, 60, 120 min and 24 hour after administration of olanzapine, and the degree of nausea relief (scale, 1-5) at 24 hour. Adverse event.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	olanzapine 5mg orally every 24 hour for 72 hours for the treatment of breakthrough nausea and vomiting induced by chemotherapy.
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	(1) Malignant tumor patients except for hematopoietic malignancy. (2) ECOG performance status 0-2. (3) 20 years-old over at the time of giving informed consent (4) Patients who have not had medical history of moderately and/or highly emetogenic chemotherapy regimen (5) CBDCA dose is AUC 5 or more. (6) Adequate organ function as defined by; AST and ALT < 5 x normal range, T-Bill <= 2.0 mg/dL. (Each of values are examined within 8days before prior to entry) (7) Oral ingestion is possible (8) Patient who got written consent from participation before registration
Key exclusion criteria	(1) Patients who has history of hypersensitivity or allergy for study drugs or similar compounds. (2) Patients who do not have enough whole body state to the antineoplastic agents treatment (3) Patient undergoing diabetes treatment (4) Patients with symptomatic brain metastasis (5) Patients who has a convulsive disorders that need anticonvulsants therapy. (6) Patients with symptomatic ascites that need therapeutic drainage. (7) Pregnant, breastfeeding or expecting woman, or patients without intention to contraception (8) Patients enforced radiotherapy on the period between 6 days before and 6 days after of the date of first therapy. (9) Patients who are using prophylactic antiemetic therapy drugs other than NK1 receptor antagonist, 5HT3 antagonist or dexamethasone. (10) Patients who take a medicine regularly antidopamine agonists, phenothiazine tranquilizers,antihistamine drugs, benzodiazepine,agents. (11) Judged by the investigator to be inappropriate for this study (12) Patients who has nausea at the start of chemotherapy (13) Patients who started opioids within 1 week of chemotherapy
Target sample size	100

Research contact person
Last name of lead principal investigator	1st name Akimitsu Middle name Last name Maeda
Organization	Aichi Cancer Center Hospital
Division name	Department of pharmacy
Zip code	464-8681
Address	1-1, Kanokoden Chikusa-ku Nagoya-shi, Aichi, Japan
TEL	052-762-6111
Email	m.akimitsu@aichi-cc.jp

Public contact
1st name of contact person	1st name Akimitsu Middle name Last name Maeda
Organization	Aichi Cancer Center Hospital
Division name	Department of pharmacy
Zip code	464-8681
Address	1-1, Kanokoden Chikusa-ku Nagoya-shi, Aichi, Japan
TEL	052-762-6111
Homepage URL
Email	m.akimitsu@aichi-cc.jp

Sponsor
Institute	Aichi Cancer Center Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Aichi Cancer Center Hospital
Address	1-1, Kanokoden Chikusa-ku Nagoya-shi, Aichi, 464-8681, Japan
Tel	052-762-6111
Email	tmushika@aichi-cc.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	2018 Year 03 Month 21 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	84
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	Completed
Date of protocol fixation	2018 Year 03 Month 21 Day
Date of IRB	2018 Year 03 Month 30 Day
Anticipated trial start date	2018 Year 04 Month 11 Day
Last follow-up date	2019 Year 03 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 03 Month 21 Day
Last modified on	2019 Year 03 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036346