UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043339 |
|---|---|
| Receipt number | R000049477 |
| Scientific Title | A comparative study of the intestinal flora of untreated postmenopausal breast cancer patients and healthy postmenopausal individuals and a preliminary study of soymilk beverage acceptability in a group of breast cancer patients |
| Date of disclosure of the study information | 2021/03/10 |
| Last modified on | 2021/02/15 23:30:17 |
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Basic information
Public title
A comparative study of the intestinal flora of untreated postmenopausal breast cancer patients and healthy postmenopausal individuals and a preliminary study of soymilk beverage acceptability in a group of breast cancer patients
Acronym
A comparative study of the intestinal flora of untreated postmenopausal breast cancer patients and healthy postmenopausal individuals and a preliminary study of soymilk beverage acceptability in a group of breast cancer patients
Scientific Title
A comparative study of the intestinal flora of untreated postmenopausal breast cancer patients and healthy postmenopausal individuals and a preliminary study of soymilk beverage acceptability in a group of breast cancer patients
Scientific Title:Acronym
A comparative study of the intestinal flora of untreated postmenopausal breast cancer patients and healthy postmenopausal individuals and a preliminary study of soymilk beverage acceptability in a group of breast cancer patients
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate acceptability of soymilk in Japanese breast cancer patients, and compare the composition of intestinal flora between patients who drink the soymilk and who do not drink
Basic objectives2
Others
Basic objectives -Others
Composition of intestinal flora before and after drinking fermented soymilk drink, before and after surgery, immunological biomarker
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Acceptability of soymilk in Japanese breast cancer patients
2) Composition of intestinal flora between patients who drink the soymilk and who do not drink
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
with soymilk
Interventions/Control_2
without soymilk
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
Female
Key inclusion criteria
(1) Postmenopausal women
(2) The age at the time of obtaining document consent is 20 years or older.
(3) ECOG Performance Status (PS) is 0 or 1.
(4) Those who have a constant daily diet and a constant daily rhythm
(5) Those whose inspection values are within the normal range
(6) Histological diagnosis of breast cancer has been obtained
(7) Primary untreated primary breast cancer without distant metastasis
(8) Scheduled surgery for breast cancer (assuming no preoperative treatment)
(9) Do not have double cancer
Key exclusion criteria
(1) Those who cannot drink soy milk
(2) Those who drink soy milk on a daily basis
(3) Those who have a history of food allergies that are problematic when participating in the study, including allergies to soybeans, milk, and soymilk.
(4) Those who regularly use foods that may affect intestinal regulation, foods for specified health use, foods with functional claims, supplements, and health foods at least 3 times a week
(5) Those who are taking antibiotics within 2 weeks before registration
(6) Those who took intestinal regulators and laxatives within 1 month before registration
(7) Alcoholic drinkers
(8) Those who have extremely irregular eating habits, those who have irregular lifestyles such as shift workers and late-night workers
(9) Those who have been treated for gastrointestinal diseases within 6 months before registration
(10) Those who have a history of surgery within 6 months before registration
(11) Those who have an active infectious disease that requires treatment
(12) Those who have diarrhea requiring treatment
(13) People with constipation who often have no bowel movements for more than a week
(14) Those who are undergoing treatment for constipation or constipation that requires treatment
(15) Those with inflammatory bowel disease
(16) Those with a BMI of 25 or above
(17) Those who have an artificial anus
(18) Those who have had intestinal obstruction (ileus) in the past
(19) Those who have had severe abdominal pain or black stools within the past week
(20) Those who are on dialysis
(21) Those who have undergone breast augmentation surgery
(22) Those who have been diagnosed with hay fever and who are taking over-the-counter medicine due to subjective symptoms of hay fever
(23) Those with severe medical illness, signs of psychiatric or neurological illness that do not comply with the provisions of this study
(24) Others who are deemed inappropriate as the subject of this study by the principal investigator, etc.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masakazu |
| Middle name | |
| Last name | Toi |
Organization
Kyoto University Hospital
Division name
Breast Surgery
Zip code
6068507
Address
54 Kawaharacho, Shogoin, Sakyo-kum, Kyoto, Japan
TEL
075-751-3660
toi@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Takada |
Organization
Kyoto University Hospital
Division name
Breast Surgery
Zip code
6068507
Address
54 Kawaharacho, Shogoin, Sakyo-kum, Kyoto, Japan
TEL
075-751-3660
Homepage URL
masahiro@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Yakult, co., jp
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-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 | 03 | Month | 10 | 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
| 2021 | Year | 02 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 09 | 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 | 02 | Month | 16 | Day |
Last modified on
| 2021 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049477
