UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An exploratory study on the anti-inflammatory effects of fucoidan in relation to quality of life in advanced cancer patients
Title of the study (Brief title)	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	Mitsuhiko Kawaguchi
Organization	Kawaguchi Medical Clinic
Division name	Division of Internal Medicine
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	Hidenori Takahashi
Organization	University of the Ryukyus Hospital
Division name	Division of Community-based Medicine and Primary Care
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://journals.sagepub.com/doi/full/10.1177/1534735417692097
Results
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