UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062299 |
|---|---|
| Receipt number | R000071278 |
| Scientific Title | A Single-Arm Exploratory Clinical Study Evaluating the Effects of Cirsium brevicaule-Derived Health Food on QOL, Inflammatory, Immunological, and Metabolic Markers, and Plasma Proteomic Profiles in Cancer Patients |
| Date of disclosure of the study information | 2026/07/30 |
| Last modified on | 2026/07/27 14:41:07 |
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Basic information
Public title
An Exploratory Study of Cirsium brevicaule Supplement in Cancer Patients
Acronym
An Exploratory Study of Cirsium brevicaule Supplement in Cancer Patients
Scientific Title
A Single-Arm Exploratory Clinical Study Evaluating the Effects of Cirsium brevicaule-Derived Health Food on QOL, Inflammatory, Immunological, and Metabolic Markers, and Plasma Proteomic Profiles in Cancer Patients
Scientific Title:Acronym
A Single-Arm Exploratory Clinical Study Evaluating the Effects of Cirsium brevicaule-Derived Health Food on QOL, Inflammatory, Immunological, and Metabolic Markers, and Plasma Proteomic Profiles in Cancer Patients
Region
| Japan |
Condition
Condition
Malignant Neoplasms (Cancer)
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Pneumology | Endocrinology and Metabolism | Hematology and clinical oncology |
| Geriatrics | Surgery in general | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Chest surgery | Endocrine surgery |
| Breast surgery | Obstetrics and Gynecology | Dermatology |
| Oto-rhino-laryngology | Orthopedics | Urology |
| Radiology | Oral surgery | Neurosurgery |
| Laboratory medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this single-arm exploratory study is to evaluate the effects of daily intake of Cirsium brevicaule-derived health food on quality of life (QOL), inflammatory, immunological, and metabolic markers, as well as plasma proteomic profiles in cancer patients, and to assess its potential efficacy and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in Quality of Life (QOL) scores from baseline to 3 months of daily intake of Cirsium brevicaule-derived health food.
Key secondary outcomes
1. Changes in inflammatory and immune markers: Time-course changes in C-reactive protein (CRP) and neutrophil-to-lymphocyte ratio (NLR).
2. Changes in metabolic markers: Time-course changes in HOMA-IR .
3. Comprehensive changes in blood proteomic profiles : Time-course changes in stress response proteins (such as HSP70, HSP90, FAM107B), IL-6, adiponectin, and approximately 11,000 other plasma proteins.
4. Changes in general blood test parameters: Time-course changes in complete blood count (WBC, RBC, Hb, Plt), liver function (AST, ALT, gamma-GTP, Total Bil), and renal function (BUN, Cr).
5. Safety evaluation: Incidence and severity of adverse events assessed according to CTCAE v5.0.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral administration of Cirsium brevicaule-derived health food (2 packets daily) for 3 months (12 weeks).
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.Male or female patients aged 20 years or older at the time of providing written informed consent.
2.Histologically or cytologically confirmed solid tumor or hematological malignancy.
3.Patients currently receiving, scheduled to receive standard anti-cancer therapy, or receiving palliative/supportive care without active anti-cancer treatment.
4.ECOG Performance Status (PS) of 0 to 2.
5.Adequate major organ function (hepatic, renal, bone marrow, etc.) determined by the primary physician as sufficient for safe participation in this study.
6.Capable of oral ingestion and expected to be compliant with the daily study food intake (twice daily).
7.Voluntarily provided written informed consent after receiving a full explanation of the study details using the informed consent document.
Key exclusion criteria
1.History of allergy to Cirsium brevicaule (Shimami Azami), Asteraceae family plants, or any components of the study food.
2.Patients participating in other clinical trials at the time of study initiation.
3.Patients with severe comorbidities deemed inappropriate for participation by the primary physician, such as severe hepatic impairment, renal impairment, heart failure, or uncontrolled diabetes.
4.Pregnant, lactating, or planning to become pregnant.
5.Patients otherwise judged by the principal investigator to be unsuitable for participation in this study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hideo |
| Middle name | |
| Last name | Nakajima |
Organization
Ageo Central General Hospital
Division name
Department of Medical Oncology
Zip code
362-8588
Address
1-10-10 Kashiwaza, Ageo-shi, Saitama , Japan
TEL
048-773-1111
nakajima.h@ach.or.jp
Public contact
Name of contact person
| 1st name | Hideo |
| Middle name | |
| Last name | Nakajima |
Organization
Ageo Central General Hospital
Division name
Department of Medical Oncology
Zip code
362-8588
Address
1-10-10 Kashiwaza, Ageo-shi, Saitama , Japan
TEL
048-773-1111
Homepage URL
nakajima.h@ach.or.jp
Sponsor or person
Institute
Ageo Central General Hospital
Institute
Department
Personal name
HIDEO NAKAJIMA
Funding Source
Organization
HUNTKEY JAPAN Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ageo Central General Hospital
Address
1-10-10 Kashiwaza, Ageo-shi, Saitama , Japan
Tel
048-773-1111
omr@ach.or.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
| 2026 | Year | 07 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 22 | Day |
Last modified on
| 2026 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071278
