UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043988 |
|---|---|
| Receipt number | R000049392 |
| Scientific Title | Feasibility study of food containing Acanthopanax senticosus for cancer related fatigue |
| Date of disclosure of the study information | 2021/04/20 |
| Last modified on | 2022/03/09 16:55:59 |
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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)
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
wtnb-n@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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049392
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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