UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031823
Receipt number R000036346
Scientific Title A phase II trial evaluating the effect of olanzapine 5mg for breakthrough nausea and vomiting in patients receiving carboplatin based chemotherapy
Date of disclosure of the study information 2018/03/21
Last modified on 2019/03/29 23:43:12

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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

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

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 or person

Institute

Aichi Cancer Center Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036346


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name