UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030785
Receipt number 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 21:09:00

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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 or person

Institute

Tottori University

Institute

Department

Personal name



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

Value
https://center6.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