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
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
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
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
