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
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
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
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
