UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041167
Receipt number 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 2023/09/12 16:19:05

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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 or person

Institute

Showa University Fujigaoka Hospital
Department of Gastroenterological and General Surgery

Institute

Department

Personal name



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

40

Results

The results showed no significant differences in any of the items between the two groups. The results of this study did not indicate the efficacy of perioperative Ninjinyoeito on weight and skeletal muscle loss after gastric cancer surgery.

Results date posted

2023 Year 09 Month 12 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Of the patients who underwent gastrectomy for a diagnosis of gastric cancer between 2020 and 2023, 40 patients who consented to the study were enrolled. 39 patients were included in the study, excluding one patient who met the postoperative exclusion criteria. 19 patients were allocated to the Ninjinyoeito group and 20 to the control group. No significant differences were found in patient background. All patients underwent body composition measurements (body weight, SMI, visceral fat) preoperatively and at 1, 3 and 6 months postoperatively.

Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

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

2023 Year 03 Month 31 Day

Date of closure to data entry

2023 Year 03 Month 31 Day

Date trial data considered complete

2023 Year 03 Month 31 Day

Date analysis concluded

2023 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2020 Year 07 Month 20 Day

Last modified on

2023 Year 09 Month 12 Day



Link to view the page

Value
https://center6.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