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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030785
Receipt No. R000031411
Scientific Title Early intervention of nutrition for patients with advanced lung cancer
Date of disclosure of the study information 2018/01/12
Last modified on 2018/12/19

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Basic information
Public title Early intervention of nutrition for patients with advanced lung cancer
Acronym Early intervention of nutrition for patients with advanced lung cancer
Scientific Title Early intervention of nutrition for patients with advanced lung cancer
Scientific Title:Acronym Early intervention of nutrition for patients with advanced lung cancer
Region
Japan

Condition
Condition lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This trial evaluates the effectiveness of nutritional aid drink containing eicosapentaenoic acid (EPA) and nourishment instruction by dietitians for patients with inoperable or recurrence of lung cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of the weight and the lean body mass three months after the intervention
Key secondary outcomes Performance States
Quality of Life
TP,Alb,Hgb,CRP,TNF-a,IL-6,IL-1B

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
Food
Interventions/Control_1 Patients consume nutritional aid drink upper limit 600mL a day for three months.Dietician instructs patients once a month.
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 Patients with inoperable or recurrence lung cancer
Patients that know disease's name.
Key exclusion criteria Patients having a severe heart failure or liver function disorder or renal function disorder
patients who have had a partial stomach excision
Patient having diabetes having poor control
Patient having mental disease having poor control
Pregnant woman
Patient with less than four months in remaining days
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Natsumi Tanaka
Organization Tottori University
Division name Division of Medical Oncology and Molecular Respirology
Zip code
Address 36-1 Nishi-cho, Yonago, Tottori, Japan
TEL 0859-38-6537
Email n.tanaka@med.tottori-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Natsumi Tanaka
Organization Tottori University
Division name Division of Medical Oncology and Molecular Respirology
Zip code
Address 36-1 Nishi-cho, Yonago, Tottori, Japan
TEL 0859-38-6537
Homepage URL
Email n.tanaka@med.tottori-u.ac.jp

Sponsor
Institute Tottori University
Institute
Department

Funding Source
Organization Nippon Kayaku
Shionogi & Co., Ltd
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
2018 Year 01 Month 12 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
2017 Year 05 Month 17 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 23 Day
Last follow-up date
2018 Year 07 Month 25 Day
Date of closure to data entry
2018 Year 08 Month 15 Day
Date trial data considered complete
2018 Year 08 Month 15 Day
Date analysis concluded
2018 Year 10 Month 18 Day

Other
Other related information

Management information
Registered date
2018 Year 01 Month 12 Day
Last modified on
2018 Year 12 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031411

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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