UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024066 |
|---|---|
| Receipt number | 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 09:39:32 |
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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
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
bzr06263@med.u-ryukyu.ac.jp
Sponsor or person
Institute
Kawaguchi Medical Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027712
| Research Plan | |
|---|---|
| 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 |
