UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016294
Receipt number R000018904
Scientific Title Effect of japanese traditional medicine, TJ-14, on QOL for patients with non-small lung cancer receiving outpatient chemotherapy
Date of disclosure of the study information 2015/02/01
Last modified on 2017/07/25 12:05:29

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Basic information

Public title

Effect of japanese traditional medicine, TJ-14, on QOL for patients with non-small lung cancer receiving outpatient chemotherapy

Acronym

Effect of TJ-14 on QOL for patients with non-small lung cancer receiving outpatient chemotherapy

Scientific Title

Effect of japanese traditional medicine, TJ-14, on QOL for patients with non-small lung cancer receiving outpatient chemotherapy

Scientific Title:Acronym

Effect of TJ-14 on QOL for patients with non-small lung cancer receiving outpatient chemotherapy

Region

Japan


Condition

Condition

non-small lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the factors influencing the QOL of TJ-14 in patients with lung cancer undergoing outpatient chemotherapy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the quality of life (QOL)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

To investigate the factors influencing the QOL for these patients, we answered using a QOL questionaire, "The QOL Questionnaire for Cancer Patients Treated with Anticancer Drugs"(QOL-ACD) to patients with non-small cell lung cancer.

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

50 years-old <=

Age-upper limit

95 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with non-small lung cancer undergoing outpatient chemotherapy of PS 0-1

Key exclusion criteria

Poor status of PS, over 2.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshihisa Ishiura

Organization

Toyama City Hospital

Division name

Oncology Medicine

Zip code


Address

2-1 Imaizumihokubumachi, Toyama City

TEL

076-422-1112

Email

ishiura@tch.toyama.toyama.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshihisa Ishiura

Organization

Toyama City Hospital

Division name

Oncology Medicine

Zip code


Address

2-1 Imaizumihokubumachi, Toyama City

TEL

076-422-1112

Homepage URL


Email

ishiura@tch.toyama.toyama.jp


Sponsor or person

Institute

Oncology Medicine of Toyama City Hospital

Institute

Department

Personal name



Funding Source

Organization

Oncology Medicine of Toyama City 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



Other administrative information

Date of disclosure of the study information

2015 Year 02 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

Open public recruiting

Date of protocol fixation

2015 Year 01 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 02 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 01 Month 21 Day

Last modified on

2017 Year 07 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018904


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name