UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of japanese traditional medicine, TJ-108, on QOL for patients with non-small lung cancer receiving outpatient chemotherapy
Title of the study (Brief title)	Effect of TJ-108 on QOL for patients with non-small lung cancer receiving outpatient chemotherapy
Region	Japan

Condition
Condition	non-small lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the factors influencing the QOL of TJ-108 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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

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. "Ninjin-Youei-Tou" is administered 2.5g 3 times after meal durung 4 weeks. Before administraion and after 4 weeks treatment of "Ninjin-Youei-Tou", QOL-ACD are conducted to evaluate QOL.
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	Yoshihisa Ishiura
Organization	Toyama City Hospital
Division name	Oncology Medicine
Address	2-1 Imaizumihokubumachi, Toyama City
TEL	076-422-1112
Email	ishiura@tch.toyama.toyama.jp

Public contact
Name of contact person	Yoshihisa Ishiura
Organization	Toyama City Hospital
Division name	Oncology Medicine
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	Toyama City
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization	Toyama City

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 03 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 14 Day
Anticipated trial start date	2016 Year 03 Month 01 Day
Last follow-up date	2017 Year 02 Month 01 Day
Date of closure to data entry	2017 Year 02 Month 01 Day
Date trial data considered complete	2017 Year 03 Month 01 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	No significant effect was observed.
Other related information	Nothing

Management information
Registered date	2016 Year 02 Month 18 Day
Last modified on	2017 Year 08 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024325