UMIN-CTR Clinical Trial

Basic information
Public title	Feasibility study to investigate the effect of Acanthopanax senticosus intake on the cancer related fatigue.
Acronym	Feasibility study to investigate the effect of Acanthopanax senticosus intake on the cancer related fatigue.
Scientific Title	Feasibility study to investigate the effect of Acanthopanax senticosus intake on the cancer related fatigue.
Scientific Title:Acronym	Feasibility study to investigate the effect of Acanthopanax senticosus intake on the cancer related fatigue.
Region	Japan

Condition
Condition	Cancer related fatigue (malaise)
Classification by specialty	Not applicable
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To explore the safety and efficacy of Acanthopanax senticosus intake in patients with cancer related fatigue.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The proportion of the patient whose BFI and FACIT-F can be evaluated at day 28.
Key secondary outcomes	# The changes in BFI score during registration and day 29. # The changes in FACIT-F subscale score during registration and day 29. # The changes in FACIT-F total score during registration and day 28. # Safety (The frequency of total adverse event). # General condition (assessed by ECOG-PS). # The changes in laboratory data.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Oral intake of 5 tablets with Organic Sun Eleuthro three times a day for 14 days.
Interventions/Control_2	Oral intake of 30 mL with Sun Eleuthro Extract a day for 14 days.
Interventions/Control_3	Oral intake of 30 mL with Sun Eleuthro Extract twice a day for 14 days.
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	# Advanced cancer patient who can take food orally and whose expected survival time is more than one month. # he score of Brief Fatigue Inventory is more than 3 or more. # Age 20 years and older # Ability to provide and written informed consent. # Patients who are receiving palliative chemotherapy are eligible for study if approved by primary oncologist prior to inclusion.
Key exclusion criteria	# The patients who have taken Acanthopanax Senticosus and are not off it for more than 3 months. # Allergy to Acanthopanax Senticosus and/or honey. # Uterus and Ovary cancer patient who are histologically confirmed with estrogen receptor positive. # The patient who received Doxifluridine (FURTULON) chemotherapy. # Uncontrolled hypertension (Blood pressure more than 180/90 mmHg) # Currently taking digoxin formulation. # Co-existence of severe complication. # Pregnant or expected to be pregnant, and breast feeding mother. # Co-existence of endometriosis and myoma uteri. # Unable to provide and written informed consent due to mental disorder. # Concomitant use of drugs which is contraindicated towards Acanthopanax Senticosus.
Target sample size	21

Research contact person
Name of lead principal investigator	1st name Kawano Middle name Last name Yutaka
Organization	Health Sciences University of Hokkaido
Division name	Institute of Preventive Medical Sciences
Zip code	0028072
Address	Ainosato 2-5-1, Kita-ku, Sapporo, Hokkaido
TEL	011-778-7575(ext.4253)
Email	ykawano@hoku-iryo-u.ac.jp

Public contact
Name of contact person	1st name Tada Middle name Last name Masahito
Organization	Higashi Sapporo Hospital
Division name	Administrative department
Zip code	0038585
Address	3-3-7-35,Higashi Sapporo,Shiroishi-ku,Sapporo, Hokkaido
TEL	011-812-2311
Homepage URL	http://www.hsh.or.jp/
Email	mtada@hsh.or.jp

Sponsor
Institute	Health Sciences University of Hokkaido
Institute
Department

Funding Source
Organization	Sun Chlorella Corporaton
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Hokubu Rinsho Co,. Ltd
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Health Sciences University of Hokkaido
Address	Ainosato 2-5-1, Kita-ku, Sapporo, Hokkaido
Tel	011-778-7575
Email	ykawano@hoku-iryo-u.ac.jp

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	医療法人　東札幌病院(北海道)

Other administrative information
Date of disclosure of the study information	2019 Year 01 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	4
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	Terminated
Date of protocol fixation	2018 Year 12 Month 03 Day
Date of IRB	2018 Year 12 Month 12 Day
Anticipated trial start date	2019 Year 01 Month 07 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 01 Month 06 Day
Last modified on	2021 Year 01 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040402