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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024066
Receipt No. R000027712
Scientific Title An exploratory study on the anti-inflammatory effects of fucoidan in relation to quality of life in advanced cancer patients
Date of disclosure of the study information 2016/09/15
Last modified on 2017/06/21

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Basic information
Public title An exploratory study on the anti-inflammatory effects of fucoidan in relation to quality of life in advanced cancer patients
Acronym An exploratory study on the anti-inflammatory effects of fucoidan in relation to quality of life in advanced cancer patients
Scientific Title An exploratory study on the anti-inflammatory effects of fucoidan in relation to quality of life in advanced cancer patients
Scientific Title:Acronym An exploratory study on the anti-inflammatory effects of fucoidan in relation to quality of life in advanced cancer patients
Region
Japan

Condition
Condition advanced cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate whether fucoidan as a supportive care agent could alleviate inflammatory conditions and maintain quality of life (QOL) in advanced cancer patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Changes in inflammatory biomarkers including high-sensitivity CRP, and pro-inflammatory cytokines (IL-1beta, IL-6, TNF-alfa) during the study period of 4w.
Key secondary outcomes Changes in QOL scores using EORTC QLQ-C30 during the study period of 4w.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 receive 400 ml/day of fucoidan (Trade name: Power Fucoidan, Daiichi Sangyo, Co. Ltd. Osaka, Japan) for at least 4 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 (1) clinically diagnosed with inoperable metastatic cancer,
(2) aged over 20 years,
(3) ambulatory as an outpatient with normal food intake for at least 4 weeks during the study,
Key exclusion criteria with serious dysfunction of vital organs.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuhiko Kawaguchi
Organization Kawaguchi Medical Clinic
Division name Division of Internal Medicine
Zip code
Address 2-2-16, Daiku, Kita-ku, Okayama-shi, Okayama Japan 700-913 Japan
TEL 086-222-0820
Email nqp02936@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Hidenori Takahashi
Organization University of the Ryukyus Hospital
Division name Division of Community-based Medicine and Primary Care
Zip code
Address 207 Uehara, Nishihara-cho, Nakagami-gun, Okinawa, 903-0215, Japan
TEL 098-895-1331
Homepage URL
Email bzr06263@med.u-ryukyu.ac.jp

Sponsor
Institute Kawaguchi Medical Clinic
Institute
Department

Funding Source
Organization Daiichi Sangyo, Co. Ltd. Osaka, Japan
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 川口メディカルクリニック(岡山県)、喜多村クリニック(福岡県)、セレンクリニック福岡(福岡県)、堂島リーガクリニック(大阪府)

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://journals.sagepub.com/doi/full/10.1177/1534735417692097
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
2013 Year 10 Month 24 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 15 Day
Last modified on
2017 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027712

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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