UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility of Olanzapine for the prevention of chemotherapy-induced nausea and vomiting in patients receiving 5-day chemotherapy rejimens
Title of the study (Brief title)	Feasibility of Olanzapine for the prevention of chemotherapy-induced nausea and vomiting in patients receiving 5-day chemotherapy rejimens
Region	Japan

Condition
Condition	Patients receiving multiple chemotherapy including highly or moderate emetogenic agents
Classification by specialty	Medicine in general Urology Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy and safety of Olanzapine for anti-emetic therapy. To decide recommended dose.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	feasibility
Key secondary outcomes	To decide recommended dose.

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Olanzapine before the chemotherapy and on day1-5 + granisetron 1 mg i.v. on day1-5 + dexamethasone 19.8mg i.v. on day1-5
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	15 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	1) patients receiving multiple chemotherapy ( 5days ) including highly or moderate emetogenic agent. 2) patients had never received any chemotherapy. 3) aged 15 years <=, 75> 4) Eeatern clinical oncology group performans status is 0 to 2. 5) fulfil all following conditions ANA >= 1,500/mm3 Plt >= 100,000/mm3 Hb>=9.0 g/dl T.Bil < 2.0 g/dl AST < 100 IU/L ALT < 100 IU/L Cre < 1.5 6) written informed consent from the patients
Key exclusion criteria	a)patients who had diabetes mellitus or past history of diabetes mellitus b)patients who take adrenaline beginning chemotherapy. c)patients who take barbituric acid beginning chemotherapy. d)patients who had received any chemotherapy. e)patients who take opioid. f)patients who have nausea or vomiting starting study. g)Active infectious diseases h)Severe complications i)history of hypersensitivity or allergy for study drugs or similar compounds. j)patients with clinically problematic, psycho-neurologic diseases k)pregnant, breastfeeding or expecting woman. l) patients with symptomatic brain metastasis m)patients with obstruction of gastrointestinal tract, for example ileus etc. n)patients who are disqualified by attending physicians o)patients with gastrointestinal cancer
Target sample size	18

Research contact person
Name of lead principal investigator	Kenji Tamura
Organization	National cancer center hospital
Division name	Breast and medical oncology
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL	03-3542-2511
Email	ketamura@ncc.go.jp

Public contact
Name of contact person	Seiko Bun
Organization	National cancer center hospital
Division name	Pharmacy
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL	03-3542-2511
Homepage URL
Email	sbun@ncc.go.jp

Sponsor
Institute	National cancer center hospital
Institute
Department

Funding Source
Organization	Foundation for Promotion of Cancer Research
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

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	2014 Year 10 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 01 Day
Anticipated trial start date	2014 Year 08 Month 01 Day
Last follow-up date	2016 Year 04 Month 10 Day
Date of closure to data entry	2016 Year 04 Month 10 Day
Date trial data considered complete	2016 Year 04 Month 10 Day
Date analysis concluded	2016 Year 09 Month 01 Day

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

Management information
Registered date	2014 Year 10 Month 09 Day
Last modified on	2017 Year 08 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017651