UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043054
Receipt number R000049150
Scientific Title Pilot study to examine efficacy of preoperative nutritional support in lung cancer patients
Date of disclosure of the study information 2021/01/19
Last modified on 2023/03/29 22:00:59

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Basic information

Public title

Pilot study to examine efficacy of preoperative nutritional support in lung cancer patients

Acronym

Pilot study to examine efficacy of preoperative nutritional support in lung cancer patients

Scientific Title

Pilot study to examine efficacy of preoperative nutritional support in lung cancer patients

Scientific Title:Acronym

Pilot study to examine efficacy of preoperative nutritional support in lung cancer patients

Region

Japan


Condition

Condition

Resectable lung cancer (histologically proven cases and clinically suspected cases before surgery)

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to examine the safety and efficacy of preoperative nutritional support for lung cancer patients in malnutrition.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Perioperative adverse events

Key secondary outcomes

Change of body composition and nutritional index (Prognostic nutritional index, PNI)
Overall survival
Recurrence-free survival
Change of muscle (hand grip) strength
Change of dietary conditions(assessed by brief-type self-administered diet history questionnaire)


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

Medicine Food

Interventions/Control_1

We will perform nutritional assessment and supportive intervention (enteric nutritional supplement if required) for patients with lung cancer while outpatient consult before lung surgery.

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

40 years-old <=

Age-upper limit

85 years-old >

Gender

Male and Female

Key inclusion criteria

1.Histologically proven primary lung cancer (including preoperatively suspected cases)
2-1. Patients in malnutrition (Prognostic nutritional status, PNI<45).
2-2. PNI is calculated as 10 x serum albumin level (g/dL)+ 0.005 x total lymphocyte count (cells/mm3 )
3.Written informed consent
4.ECOG performance status:0-2

Key exclusion criteria

1.Biopsy cases
2.Patients with Systemic inflammatory disease
3.Patients treating diabetes mellitus using insulin
4.Patients treating hyperlipidemia using drugs
5.Patients using oral steroids for a long term
6.Pregnant and lactating patients
7.Patients considered as inappropriate by physicians

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Akihiro
Middle name
Last name Aoyama

Organization

Kyoto Katsura Hospital

Division name

Thoracic Surgery

Zip code

615-8256

Address

17 Yamada Hirao, Nishikyo, Kyoto

TEL

075-391-5811

Email

ao.akihiro@gmail.com


Public contact

Name of contact person

1st name Akihiro
Middle name
Last name Aoyama

Organization

Kyoto Katsura Hospital

Division name

Thoracic Surgery

Zip code

615-8256

Address

17 Yamada Hirao, Nishikyo, Kyoto

TEL

075-391-5811

Homepage URL


Email

ao.akihiro@gmail.com


Sponsor or person

Institute

Kyoto Katsura Hospital

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyoto Katsura Hospital Ethics Board

Address

17 Yamada Hirao, Nishikyo, Kyoto

Tel

075-391-5811

Email

noriko.fujita@katsura.com


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

京都桂病院(京都府)


Other administrative information

Date of disclosure of the study information

2021 Year 01 Month 19 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

No longer recruiting

Date of protocol fixation

2020 Year 12 Month 02 Day

Date of IRB

2020 Year 12 Month 02 Day

Anticipated trial start date

2021 Year 01 Month 19 Day

Last follow-up date

2027 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 01 Month 19 Day

Last modified on

2023 Year 03 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049150


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name