UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000033309 |
|---|---|
| Receipt number | R000037972 |
| Scientific Title | The anti-inflammatory effect of fish oil enriched with EPA on cancer patients |
| Date of disclosure of the study information | 2018/07/07 |
| Last modified on | 2020/01/06 18:46:01 |
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Basic information
Public title
The anti-inflammatory effect of fish oil enriched with EPA on cancer patients
Acronym
The effect of fish oil on cancer patients
Scientific Title
The anti-inflammatory effect of fish oil enriched with EPA on cancer patients
Scientific Title:Acronym
The effect of fish oil on cancer patients
Region
| Japan |
Condition
Condition
Cancer patients
Classification by specialty
| Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the anti-inlflammatory effect of fish oil on cancer patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CRP, IL-6, Albumin, Prealbumin
Key secondary outcomes
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
Subjects ingest fish oil (EPA 498mg) and a high high-calorie jelly (energy 100kcal, protein 5g) for 8 weeks.
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
Carcinoma patients
Outpatients
CRP over 0.30 mg/dl
Aged 20 or older
Oral Ingestible patients
Patients who are expected to receive regular ambulatory treatment over 6 months
Key exclusion criteria
Food allergies to fish, milk, soybean or gelatin
Taking supplement containing fish oil or EPA and DHA drugs
Use of steroidal anti-inflammatory drugs
Participation in another clinical study
Patients who have difficulties to complete the trial
Patients who are assessed by the principal investigator to be unsuitable to participate in the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Tanaka |
Organization
Iga City General Hospital
Division name
Surgery
Zip code
Address
831, Shizyuku-cho, Iga, Mie
TEL
0595-24-1111
qoujitanaka@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Tanaka |
Organization
Iga City General Hospital
Division name
Surgery
Zip code
Address
831, Shizyuku-cho, Iga, Mie
TEL
0595-24-1111
Homepage URL
qoujitanaka@yahoo.co.jp
Sponsor or person
Institute
Iga City General Hospital
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry Co, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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 | 07 | Month | 07 | 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 | 06 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 06 | Day |
Last modified on
| 2020 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037972
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
