UMIN-CTR Clinical Trial

Public title

Low emetic chemotherapy induced nausea and vomiting: A prospective, multicenter, observational study

Acronym

Low emetic chemotherapy induced nausea and vomiting: A prospective, multicenter, observational study

Scientific Title

Low emetic chemotherapy induced nausea and vomiting: A prospective, multicenter, observational study

Scientific Title:Acronym

Low emetic chemotherapy induced nausea and vomiting: A prospective, multicenter, observational study

Region

Japan

Condition

Malignant neoplasm

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The aim of the study is to investigate the incidence of CINV and the risk factors predicting CINV in cancer patients in the first cycle of LEC.

Basic objectives2

Others

Basic objectives -Others

The incidence of CINV and the risk factors predicting CINV in LEC

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

The incidence of CINV and the risk factors predicting CINV in LEC

Key secondary outcomes

1.incidence of CINV (overall, acute phase and delayed phase)
2.pattern of nausea incidence and severity
3.decrease of food intake
4.rescue medication use

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1.Male and female patients (aged over 20 years) who were low emetic chemotherapy naive and scheduled to receive at least one cycles of chemotherapy
2.Patients can note in the patient diaries
3.Patients gave written informed consent

Key exclusion criteria

1.Patients experienced CINV within 24 hours before chemotherapy
2.Patients judged unqualified for any reasons by the principal investigator or investigators at study sites

Target sample size

200

Name of lead principal investigator

1st name
Middle name
Last name	Toshinobu Hayashi

Organization

National Kyushu Medical Center

Division name

Department of pharmacy

Zip code

Address

1-8-1 Jigyohama, Chuo-ku, Fukuoka, JAPAN

TEL

092-852-0700

Email

nenten-ph@umin.org

Name of contact person

1st name
Middle name
Last name	Toshinobu Hayashi

Organization

National Kyushu Medical Center

Division name

Department of pharmacy

Zip code

Address

1-8-1 Jigyohama, Chuo-ku, Fukuoka, JAPAN

TEL

092-852-0700

Homepage URL

Email

nenten-ph@umin.org

Institute

Commitee of academic, society of pharmacist in national hospital organization kyushu

Institute

Department

Personal name

Organization

POLICY-BASED MEDICAL SERVICE FOUNDATION

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

九州がんセンター（福岡県）
九州医療センター（福岡県）
熊本医療センター（熊本県）
長崎医療センター（長崎県）
別府医療センター（大分県）
鹿児島医療センター（鹿児島県）
小倉医療センター（福岡県）
佐賀病院（佐賀県）
都城病院（宮崎県）
熊本再春荘病院（熊本県）
嬉野医療センター（佐賀県）
福岡病院（福岡県）

Date of disclosure of the study information

2016

Year

01

Month

29

Day

URL releasing protocol

Publication of results

Partially published

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

Recruitment status

Completed

Date of protocol fixation

2013

Year

04

Month

15

Day

Date of IRB

Anticipated trial start date

2013

Year

09

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Design:
Cohort study

This prospective observational study was conducted from August 2013 to July 2014.

Patients:
Male and female patients (aged over 20 years) who were chemotherapy naive and scheduled to receive at least one cycles of single-day LEC were eligible for inclusion in the study.

Key inclusion criteria:
1.Male and female patients (aged over 20 years) who were low emetic chemotherapy naive and scheduled to receive at least one cycles of chemotherapy
2.Patients can note in the patient diaries
3.Patients gave written informed consent

Exclusion criteria:
1.Patients experienced CINV within 24 hours before chemotherapy
2.Patients judged unqualified for any reasons by the principal investigator or investigators at study sites

Procedures:
Patients completed the daily diary beginning before chemotherapy (on day 1) and for a total of five calendar days.
Patients recorded the time and date of emetic episodes, the severity of nausea and food intake (0-100 VAS), and use of rescue
medication (type and dosage).

Registered date

2016

Year

01

Month

29

Day

Last modified on

2016

Year

02

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024009