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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033309
Receipt No. R000037972
Official scientific title of the study 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 2018/07/06

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Basic information
Official scientific title of the study The anti-inflammatory effect of fish oil enriched with EPA on cancer patients
Title of the study (Brief title) 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 Koji Tanaka
Organization Iga City General Hospital
Division name Surgery
Address 831, Shizyuku-cho, Iga, Mie
TEL 0595-24-1111
Email qoujitanaka@yahoo.co.jp

Public contact
Name of contact person Koji Tanaka
Organization Iga City General Hospital
Division name Surgery
Address 831, Shizyuku-cho, Iga, Mie
TEL 0595-24-1111
Homepage URL
Email qoujitanaka@yahoo.co.jp

Sponsor
Institute Iga City General Hospital
Institute
Department

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 06 Month 15 Day
Anticipated trial start date
2018 Year 07 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 07 Month 06 Day
Last modified on
2018 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037972

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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