UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021312
Receipt number R000024578
Scientific Title Hearing investigation of the lassitude for the cancer connection to the patient who enforced anticancer agent treatment in the municipal Hakodate hospital obstetrics and gynecology department
Date of disclosure of the study information 2016/04/01
Last modified on 2017/07/12 16:05:13

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Basic information

Public title

Hearing investigation of the lassitude for the cancer connection to the patient who enforced anticancer agent treatment in the municipal Hakodate hospital obstetrics and gynecology department

Acronym

Hearing investigation of the lassitude for the cancer connection to the patient who enforced anticancer agent treatment in the municipal Hakodate hospital obstetrics and gynecology department

Scientific Title

Hearing investigation of the lassitude for the cancer connection to the patient who enforced anticancer agent treatment in the municipal Hakodate hospital obstetrics and gynecology department

Scientific Title:Acronym

Hearing investigation of the lassitude for the cancer connection to the patient who enforced anticancer agent treatment in the municipal Hakodate hospital obstetrics and gynecology department

Region

Japan


Condition

Condition

Patients who underwent anti-cancer drug treatment for gynecological cancer

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Investigation of malaise to an anti-cancer drug treatment

Basic objectives2

Others

Basic objectives -Others

Evaluation of the malaise in the Japanese version of BFI

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The extent of the malaise

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

90 years-old >=

Gender

Female

Key inclusion criteria

Anti-cancer drug treatment enforcement in Obstetrics and Gynecology

Key exclusion criteria

Anti-cancer drug treatment not yet come into force at the Department of Obstetrics and Gynecology

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yukio Sakata

Organization

Hakodate Municipal Hospital

Division name

Pharmaceutical department

Zip code


Address

1-10-1,Minatochiou,Hakodate,Hokkaido,Japan

TEL

0138-43-2000

Email

y-sakata@hospital.hakodate.hokkaido.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yukio Sakata

Organization

Hakodate Municipal Hospital

Division name

Pharmaceutical department

Zip code


Address

1-10-1,Minatochiou,Hakodate,Hokkaido,Japan

TEL

0138-43-2000

Homepage URL


Email

y-sakata@hospital.hakodate.hokkaido.jp


Sponsor or person

Institute

Hakodate Municipal Hospital

Institute

Department

Personal name



Funding Source

Organization

Hakodate Municipal Hospital

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


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

市立函館病院(北海道)


Other administrative information

Date of disclosure of the study information

2016 Year 04 Month 01 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


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

2016 Year 02 Month 17 Day

Date of IRB


Anticipated trial start date

2016 Year 04 Month 01 Day

Last follow-up date

2017 Year 03 Month 31 Day

Date of closure to data entry

2017 Year 03 Month 31 Day

Date trial data considered complete

2017 Year 04 Month 30 Day

Date analysis concluded

2017 Year 05 Month 31 Day


Other

Other related information

Case-referent study
Subject:Everyone who underwent anti-cancer drug treatment in hospital obstetrics and gynecology from April 1,2016 until March 31,2017
Evaluation item:Evaluation of general malaise after a lapse of more than five days after anti-cancer drug therapy using a Japanese BFI


Management information

Registered date

2016 Year 03 Month 03 Day

Last modified on

2017 Year 07 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024578


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name