UMIN-CTR Clinical Trial

Basic information
Public title	Feasibility study of food containing Acanthopanax senticosus for cancer related fatigue
Acronym	Feasibility study of food containing Acanthopanax senticosus for cancer related fatigue
Scientific Title	Feasibility study of food containing Acanthopanax senticosus for cancer related fatigue
Scientific Title:Acronym	Feasibility study of food containing Acanthopanax senticosus for cancer related fatigue
Region	Japan

Condition
Condition	Cancer related fatigue (malaise)
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To explore the safety and efficacy of food containing Acanthopanax senticosus 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 can be evaluated at "visit 2".
Key secondary outcomes	# The rate of improvement in cancer-related fatigue # The changes in laboratory data # Safety (The frequency of total adverse event)

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	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Oral intake of 60 mL of Acanthopanax senticosus extract for 28 days.
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 Advanced cancer patient who can take food orally and whose expected survival time is more than one month #2 The score of Brief Fatigue Inventory is more than 3 or more #3 Age 20 years and older #4 Ability to provide and written informed consent
Key exclusion criteria	#1 The patients who have taken Acanthopanax Senticosus and are not off it for more than 3 months. #2 Allergy to Acanthopanax Senticosus and/or chlorella and/or honey. #3 Breast, uterus and ovary cancer patient who are histologically confirmed with estrogen receptor positive. #4 The patient who received Doxifluridine (FURTULON) chemotherapy. #5 Uncontrolled hypertension (Blood pressure more than 180/90 mmHg) #6 Currently taking digoxin formulation. #7 Co-existence of severe complication. #8 Pregnant or expected to be pregnant, and breast feeding mother. #9 Co-existence of endometriosis and myoma uteri. #10 Unable to provide and written informed consent due to mental disorder. #11 Concomitant use of drugs which is contraindicated towards either Acanthopanax Senticosus or chlorella.
Target sample size	15

Research contact person
Name of lead principal investigator	1st name YUTAKA Middle name Last name KAWANO
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 NANAE Middle name Last name WATANABE
Organization	Higashi Sapporo Hospital
Division name	Department of Internal Medicine
Zip code	0038585
Address	3-3-7-35,Higashi Sapporo,Shiroishi-ku,Sapporo, Hokkaido
TEL	011-812-2311
Homepage URL
Email	wtnb-n@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

Other related organizations
Co-sponsor	f-CRO Office
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Center for preventive medicine, Health Sciences University of Hokkaido
Address	Ainosato 2-5-1, Kita-ku, Sapporo,Hokkaido
Tel	011-778-7575
Email	mish@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

Other administrative information
Date of disclosure of the study information	2021 Year 04 Month 20 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	2021 Year 04 Month 19 Day
Date of IRB	2021 Year 04 Month 19 Day
Anticipated trial start date	2021 Year 04 Month 19 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	2021 Year 04 Month 20 Day
Last modified on	2022 Year 03 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049392