UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015386
Receipt number R000017651
Scientific Title Feasibility of Olanzapine for the prevention of chemotherapy-induced nausea and vomiting in patients receiving 5-day chemotherapy rejimens
Date of disclosure of the study information 2014/10/09
Last modified on 2017/08/27 19:18:44

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Basic information

Public title

Feasibility of Olanzapine for the prevention of chemotherapy-induced nausea and vomiting in patients receiving 5-day chemotherapy rejimens

Acronym

Feasibility of Olanzapine for the prevention of chemotherapy-induced nausea and vomiting in patients receiving 5-day chemotherapy rejimens

Scientific Title

Feasibility of Olanzapine for the prevention of chemotherapy-induced nausea and vomiting in patients receiving 5-day chemotherapy rejimens

Scientific Title:Acronym

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

1st name
Middle name
Last name Kenji Tamura

Organization

National cancer center hospital

Division name

Breast and medical oncology

Zip code


Address

5-1-1 Tsukiji, Chuo-ku, Tokyo

TEL

03-3542-2511

Email

ketamura@ncc.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Seiko Bun

Organization

National cancer center hospital

Division name

Pharmacy

Zip code


Address

5-1-1 Tsukiji, Chuo-ku, Tokyo

TEL

03-3542-2511

Homepage URL


Email

sbun@ncc.go.jp


Sponsor or person

Institute

National cancer center hospital

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2014 Year 07 Month 01 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017651


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name