UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035464 |
|---|---|
| Receipt number | R000040402 |
| Scientific Title | 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 | 2021/01/12 11:26:36 |
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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)
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/
mtada@hsh.or.jp
Sponsor or person
Institute
Health Sciences University of Hokkaido
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040402
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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