UMIN-CTR Clinical Trial

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
Email	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
Email	masahiro@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049477