UMIN-CTR Clinical Trial

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
Email	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
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037972