Unique ID issued by UMIN | UMIN000043988 |
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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 |
Feasibility study of food containing Acanthopanax senticosus for cancer related fatigue
Feasibility study of food containing Acanthopanax senticosus for cancer related fatigue
Feasibility study of food containing Acanthopanax senticosus for cancer related fatigue
Feasibility study of food containing Acanthopanax senticosus for cancer related fatigue
Japan |
Cancer related fatigue (malaise)
Hematology and clinical oncology |
Malignancy
NO
To explore the safety and efficacy of food containing Acanthopanax senticosus in patients with cancer related fatigue.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
The proportion of the patient whose BFI can be evaluated at "visit 2".
# The rate of improvement in cancer-related fatigue
# The changes in laboratory data
# Safety (The frequency of total adverse event)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
1
Treatment
Food |
Oral intake of 60 mL of Acanthopanax senticosus extract for 28 days.
20 | years-old | <= |
Not applicable |
Male and Female
#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
#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.
15
1st name | YUTAKA |
Middle name | |
Last name | KAWANO |
Health Sciences University of Hokkaido
Institute of Preventive Medical Sciences
0028072
Ainosato 2-5-1, Kita-ku, Sapporo, Hokkaido
011-778-7575(ext.4253)
ykawano@hoku-iryo-u.ac.jp
1st name | NANAE |
Middle name | |
Last name | WATANABE |
Higashi Sapporo Hospital
Department of Internal Medicine
0038585
3-3-7-35,Higashi Sapporo,Shiroishi-ku,Sapporo, Hokkaido
011-812-2311
wtnb-n@hsh.or.jp
Health Sciences University of Hokkaido
Sun Chlorella Corporaton
Profit organization
f-CRO Office
Center for preventive medicine, Health Sciences University of Hokkaido
Ainosato 2-5-1, Kita-ku, Sapporo,Hokkaido
011-778-7575
mish@hoku-iryo-u.ac.jp
NO
2021 | Year | 04 | Month | 20 | Day |
Unpublished
Completed
2021 | Year | 04 | Month | 19 | Day |
2021 | Year | 04 | Month | 19 | Day |
2021 | Year | 04 | Month | 19 | Day |
2022 | Year | 03 | Month | 31 | Day |
2021 | Year | 04 | Month | 20 | Day |
2022 | Year | 03 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049392
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