UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033589 |
|---|---|
| Receipt number | R000038300 |
| Scientific Title | The feasibility of nutritional supportive care with an eicosapentaenoic acid (EPA)-enriched nutrition agent during pre-operative chemoradiotherapy for pancreatic cancer: prospective randomized control study |
| Date of disclosure of the study information | 2018/08/01 |
| Last modified on | 2018/08/01 21:02:21 |
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Basic information
Public title
The feasibility of nutritional supportive care with an eicosapentaenoic acid (EPA)-enriched nutrition agent during pre-operative chemoradiotherapy for pancreatic cancer: prospective randomized control study
Acronym
Nutrition support for PC patients with NACRT
Scientific Title
The feasibility of nutritional supportive care with an eicosapentaenoic acid (EPA)-enriched nutrition agent during pre-operative chemoradiotherapy for pancreatic cancer: prospective randomized control study
Scientific Title:Acronym
Nutrition support for PC patients with NACRT
Region
| Japan |
Condition
Condition
Resectable and borderline resectable pancreatic cancer pateints
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the fasibility of Eicosapentaenoic acid (EPA) enriched nutrition support during neoadjuvant chemoradiotherapy for pancreatic cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The before-to-after NACRT ratios (post/pre ratios) of skeletal muscle mass and psoas major muscle area (PMA)
Key secondary outcomes
The post/pre ratios of other nutritional parameters and treatment-related toxicities
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Patients assigned to the Nutrition intervention group received 2 bottles (440 ml) per day (560 kcal/day) of EPA-enriched nutritional supplement (Prosure; Abbott Japan, Tokyo, Japan) during the irradiation component of treatment (about 5 weeks).
Interventions/Control_2
Patients assigned to the Normal diet group have usual meal without special nutritional agent
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients are enrolled in the study when they diagnose with untreated, histopathologically-confirmed, resectable pancreatic cancer (clinical stage IIA or IIB, according to TNM classification, 7th edition and scheduled to receive neoadjuvant chemoradiotherapy (NACRT)
Key exclusion criteria
Patients were excluded from the study when they don't met the following eligibility criteria: (1) an Eastern Cooperative Oncology Group performance status of 0-1; (2) adequate hepatic, renal, and bone-marrow reserves (AST and ALT levels below twice the normal levels; total serum bilirubin <3.0 mg/dl; creatinine level <1.3 mg/dl; leukocyte count>2,000/mm3; hemoglobin >10 g/dl; platelet count >100,000/mm3); (3) capable of oral intake, and (4) written informed consent provided before randomization.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidenori Takahashi |
Organization
Osaka International Cancer Institute
Division name
Department of Surgery
Zip code
Address
3-1-69, Otemae, Chuo-ku, Osaka City, Osaka, 541-8567, JAPAN
TEL
06-6945-1181
takahasi-hi@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidenori Takahashi |
Organization
Osaka International Cancer Institute
Division name
Department of Surgery
Zip code
Address
3-1-69, Otemae, Chuo-ku, Osaka City, Osaka, JAPAN
TEL
06-6945-1181
Homepage URL
takahasi-hi@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
Funding Source
Organization
The Osaka Foundation for The Prevention of Cancer and Life-style related Diseases
Organization
Division
Category of Funding Organization
Non profit foundation
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
大阪国際がんセンター(大阪府)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 01 | 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
| 2014 | Year | 03 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 01 | Day |
Last modified on
| 2018 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038300
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| Registered date | File name |
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| Registered date | File name |
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