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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035464
Receipt No. R000040402
Official scientific title of the study Feasibility study to investigate the effect of Acanthopanax senticosus intake on the cancer related fatigue.
Date of disclosure of the study information 2019/01/07
Last modified on 2019/01/07

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Basic information
Official scientific title of the study Feasibility study to investigate the effect of Acanthopanax senticosus intake on the cancer related fatigue.
Title of the study (Brief title) 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 4 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.
# Patients who have completed 1st cycle of palliative IV chemotherapy and are deemed stable by primary oncologist are eligible for study if approved by primary oncologist.
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 Yutaka Kawano
Organization Health Sciences University of Hokkaido
Division name Institute of Preventive Medical Sciences
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 Masahito Tada
Organization Higashi Sapporo Hospital
Division name Administrative department
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)

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 12 Month 03 Day
Anticipated trial start date
2019 Year 01 Month 07 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2019 Year 01 Month 06 Day
Last modified on
2019 Year 01 Month 07 Day


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

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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