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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041167
Receipt No. R000047009
Scientific Title Efficacy of perioperative Ninjin-yoei-to administration for skeletal muscle mass and weight loss after gastrectomy for gastric cancer: a randomised open-label trial
Date of disclosure of the study information 2020/08/01
Last modified on 2020/07/20

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Basic information
Public title Efficacy of perioperative Ninjin-yoei-to administration for skeletal muscle mass and weight loss after gastrectomy for gastric cancer: a randomised open-label trial
Acronym Efficacy of perioperative Ninjin-yoei-to administration for skeletal muscle mass and weight loss after gastrectomy for gastric cancer: a randomised open-label trial
Scientific Title Efficacy of perioperative Ninjin-yoei-to administration for skeletal muscle mass and weight loss after gastrectomy for gastric cancer: a randomised open-label trial
Scientific Title:Acronym Efficacy of perioperative Ninjin-yoei-to administration for skeletal muscle mass and weight loss after gastrectomy for gastric cancer: a randomised open-label trial
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the efficacy of perioperative Ninjin-yoei-to administration for skeletal muscle mass and weight loss after gastrectomy for gastric cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change rate of skeletal muscle mass and body weight 1, 3 and 6 months after gastrectomy
Key secondary outcomes Perioperative systemic inflammation markers, body composition analysis, grip strength, postoperative complications, surgery-related death

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The arm of Ninjin-yoei-to.
Take 2.5 g of Ninjin-yoei-to before each meal or between meals. The oral period will be from 2 weeks before surgery to 24 weeks after surgery.
Interventions/Control_2 Do not take Ninjin-yoei-to.
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) Patients who are admitted to outpatient department of gastroenterology or general surgery at Showa University Fujigaoka Hospital
2) Patients with histologically confirmed gastric cancer
3) Patients with clinical progress I to III who meet the indication for gastrectomy according to the 5th edition of the Guideline for Gastric Cancer Treatment
4)Patients who are 20 years or older and have PS0 or 1 at the time of obtaining consent
5)Patients who gave their informed consent to participate in this trial
Key exclusion criteria 1) Patients with residual gastric cancer
2) Patients with gastrointestinal obstruction due to tumor
3) Patients who received preoperative chemotherapy or radiation therapy for gastric cancer
4) Patients who perform simultaneous resection of other organs other than gallbladder
5) Patients with infectious diseases that require systemic treatment
6) Patients who have comorbidies, or who are taking oral medication that interferes with the determination of efficacy in measuring the number of white blood cells and lymphocytes.
7) Patients with serious liver/renal disorders or cardiopulmonary diseases that may affect the safety evaluation of drugs
8) Patients who have been given Chinese herbal medicines 4 weeks before the start of the study
9)Patients who have a history of allergy to herbal medicine
10) Patients who are judged to be ineligible by the research doctor
Target sample size 40

Research contact person
Name of lead principal investigator
1st name tsuneyuki
Middle name
Last name uchida
Organization Showa University Fujigaoka Hospital
Division name Department of Gastroenterological and General Surgery
Zip code 2278501
Address 1-30, Fujigaoka, Aoba-ku, Yokohama, kanagawa 2278501 JAPAN
TEL 045-971-1151
Email t_uchida@med.showa-u.ac.jp

Public contact
Name of contact person
1st name tsuneyuki
Middle name
Last name uchida
Organization Showa University Fujigaoka Hospital
Division name Department of Gastroenterological and General Surgery
Zip code 2278501
Address 1-30, Fujigaoka, Aoba-ku, Yokohama, kanagawa 2278501 JAPAN
TEL 045-971-1151
Homepage URL
Email t_uchida@med.showa-u.ac.jp

Sponsor
Institute Showa University Fujigaoka Hospital
Department of Gastroenterological and General Surgery
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Showa University Fujigaoka Hospital Clinical trial Review Board
Address 1-30, Fujigaoka, Aoba-ku, Yokohama, kanagawa 2278501 JAPAN
Tel 045-974-6329
Email f-irb@cmed.showa-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 昭和大学藤が丘病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2020 Year 08 Month 01 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
2020 Year 07 Month 07 Day
Date of IRB
2020 Year 07 Month 07 Day
Anticipated trial start date
2020 Year 08 Month 01 Day
Last follow-up date
2021 Year 12 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
2020 Year 07 Month 20 Day
Last modified on
2020 Year 07 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047009

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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