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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016294
Receipt No. 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

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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
Institute Oncology Medicine of Toyama City Hospital
Institute
Department

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
URL(English) https://upload.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


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