UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Japan Nutrition and QOL survey in patients with advanced non-small cell Lung Cancer study (TORG0912)
Title of the study (Brief title)	Japan Nutrition and QOL survey in patients with advanced non-small cell Lung Cancer study (TORG0912)
Region	Japan

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

Objectives
Narrative objectives1	To examine this study will be conducted the course of clinical parameter in stage 4 non small cell lung cancer, and to examine the relationship between body weight changes and QOL changes
Basic objectives2	Others
Basic objectives -Others	Prospective observation study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Body weight QOL evaluation (MDASI-J and QOL-ACD)
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Non-small cell lung cancer (Histologically or cytologically confirmed) 2) Stage IV disease by UICC-TNM 3) Non-small cell lung cancer patients without treatment history 4) ECOG performance status must be 0-2
Key exclusion criteria	1) Patients with planned surgery throughout study participation 2) Patients without capacity to consent 3) Patient who passed over 2month since disease diagnosis 4) Patients without capacity to fill out their QOL survey sheet correctly. 5) Patients without capacity to perform handgrip test (only at the sites which evaluate Handgrip strength) 6) Patients without notification of their cancer disease 7) Concomitant malignancy 8) Patients with potential disease affecting food intake 9) Patients with uncontrolled severe diabetes which may bring rapid body weight decrease. 10) Patients with uncontrolled psychiatric disorder 11) Patients with potential disease affecting QOL survey and handgrip test. 12) Patient who have other conditions judged by investigator not to be suitable for this study participation
Target sample size	440

Research contact person
Name of lead principal investigator	Kenji Eguchi
Organization	Teikyo university school of medicine
Division name	Division of Medical oncology
Address	2-11-1, KAGA, ITABASHI-KU TOKYO 173-8606 JAPAN
TEL	03-3964-1211
Email	keguchi@med.teikyo-u.ac.jp

Public contact
Name of contact person	Hiroyuki Kojima
Organization	Thoracic Oncology Research Group, TORG
Division name	Head office
Address	LA.PRYLE 822, 3-1-2, Shin-Yokohama, Kohoku-ku, 222-0033, JAPAN
TEL	045-479-8948
Homepage URL	https://www.torg.or.jp
Email	torg-kashiro@song.ocn.ne.jp

Sponsor
Institute	Thoracic Oncology Research Group,TORG
Institute
Department

Funding Source
Organization	ONO PHARMACUTICAL CO., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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	2010 Year 05 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 01 Month 25 Day
Anticipated trial start date	2010 Year 02 Month 01 Day
Last follow-up date	2011 Year 07 Month 01 Day
Date of closure to data entry	2011 Year 10 Month 01 Day
Date trial data considered complete	2011 Year 12 Month 01 Day
Date analysis concluded	2011 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.ncbi.nlm.nih.gov/pubmed/27003901
Results
Other related information	Prospective observation study. Register the patients who meet registration criteria, and follow their clinical course for 1 year.

Management information
Registered date	2010 Year 05 Month 18 Day
Last modified on	2019 Year 02 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004181