UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035851
Receipt number R000040844
Scientific Title Clinical analysis of preoperative immune-nutritional support for lung cancer patients
Date of disclosure of the study information 2019/02/12
Last modified on 2020/08/14 10:29:53

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Basic information

Public title

Clinical analysis of preoperative immune-nutritional support for lung cancer patients

Acronym

Preoperative immune-nutritional support for lung cancer patients

Scientific Title

Clinical analysis of preoperative immune-nutritional support for lung cancer patients

Scientific Title:Acronym

Preoperative immune-nutritional support for lung cancer patients

Region

Japan


Condition

Condition

Preoperative lung cancer patients

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety and efficacy of preoperative immune-nutritional support of lung cancer patients

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Rate of preoperative immune-nutritional index

Key secondary outcomes

1.Time course of preoperative hematological data
2.Postoperative complications
3.Postoperative hospital stay
4.Adverse events of immune-nutritants


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Immune-nutritants(Impact 4 packs/day x 7 days, Main 3 packs/day x 5 days, Abound 2 packs/day x 14 days)
Hematological and biochemical examination day before immune-nutritional support and 1 day before operation and 1, 3, 7 and 28 days after operation

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

Preoperative non-small cell lung cnacer patients
preoperative lymphocytes < 1600/micro l
preoperative serum albumin < 3.5g/dl
preoperative serum total cholesterol < 180mg/dl
<90% of standard body weight

Key exclusion criteria

Inflammatory diseases
Drug of anti-heperlipidemia or systemic steroids
Pregnant status

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Fumihiro
Middle name
Last name Shoji

Organization

Kyushu Medical Center

Division name

Department of thoracic surgery

Zip code

810-0063

Address

1-8-1 jigyohama, chuo-ku, Fukuoka

TEL

092-852-0700

Email

fshoji@surg2.med.kyushu-u.ac.jp


Public contact

Name of contact person

1st name Fumihiro
Middle name
Last name Shoji

Organization

Kyushu Medical Center

Division name

Department of thoracic surgery

Zip code

810-0063

Address

1-8-1 jigyohama, chuo-ku, Fukuoka

TEL

092-852-0700

Homepage URL


Email

fshoji@surg2.med.kyushu-u.ac.jp


Sponsor or person

Institute

Kyushu Medical Center

Institute

Department

Personal name



Funding Source

Organization

Kyushu Medical Center

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

Kyushu Medical Center

Address

1-8-1 Jigyohama, Chuo-ku, Fukuoka

Tel

092-852-0700

Email

fshoji@surg2.med.kyushu-u.ac.jp


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

2019 Year 02 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

2018 Year 10 Month 07 Day

Date of IRB

2018 Year 11 Month 30 Day

Anticipated trial start date

2018 Year 12 Month 01 Day

Last follow-up date

2019 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 02 Month 12 Day

Last modified on

2020 Year 08 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040844


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name