UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043792
Receipt number R000049984
Scientific Title Effect of suppressing the onset of cancer cachexia of Ninjin-yoei-To;Randomized Controlled Trial
Date of disclosure of the study information 2021/04/01
Last modified on 2023/10/02 12:40:13

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Basic information

Public title

Effect of suppressing the onset of cancer cachexia of Ninjin-yoei-To;Randomized Controlled Trial

Acronym

Effect of suppressing the onset of cancer cachexia of Ninjin-yoei-To;Randomized Controlled Trial

Scientific Title

Effect of suppressing the onset of cancer cachexia of Ninjin-yoei-To;Randomized Controlled Trial

Scientific Title:Acronym

Effect of suppressing the onset of cancer cachexia of Ninjin-yoei-To;Randomized Controlled Trials

Region

Japan


Condition

Condition

Gastric Cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate whether early intervention from pre-cachexia with Ninjin-yoei-to can maintain skeletal muscle mass in cancer patients and suppress the onset of cachexia.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Difference in time to onset of cachexia

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Ninjin-Yoei-To 3.0g / time 3 times a day before meals.

From the date of registration, the drug used will be administered daily according to the above usage.

Interventions/Control_2

Standard treatment without 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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1.Adults between the ages of 20 and 80 at the time of registration.
2,Histologically diagnosed as adenocarcinoma by biopsy from the primary tumor of the stomach.
3. The diagnosis is stage IV, which cannot be completely resected by diagnostic imaging.
4. Patients who can receive chemotherapy with Performance Status (PS) 0-1.
5. Chemotherapy has not been performed at the time of registration.
6. Does not meet the diagnostic criteria for cachexia by European Palliative Care Research Collaborative (EPCRC). The diagnostic criteria are as follows.
1)Over 5% weight loss in the last 6 months
2)Patients with BMI <20 kg / m2 have more than 2% weight loss
3)Extremity skeletal muscle index (male 7.26 kg / m2, female <5.45 kg / m2) indicating sarcopenia, and any weight loss greater than 2%
7. It is possible to take medicine internally.
8. Consent has been obtained for participation in this study.

Key exclusion criteria

1.Have active multiple cancers.
2. There is an active infectious disease.
3. Have clinically problematic diseases (collagen disease, renal failure, interstitial pneumonia, etc.)
4. It is judged that it is difficult to participate in the research because of mental illness or psychiatric symptoms.
5. In addition, the doctor in charge judges that it is inappropriate as the subject of this study.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Kazuhide
Middle name
Last name Higuchi

Organization

Osaka Medical and Pharmaceutical College

Division name

Second Department of Internal Medicine

Zip code

569-8686

Address

Takatsuki city, Daigakutyo,2-7,Osaka

TEL

072-683-1221

Email

kazuhide.higuchi@ompu.ac.jp


Public contact

Name of contact person

1st name Masahiro
Middle name
Last name Goto

Organization

Osaka Medical and Pharmaceutical College

Division name

Cancer Chemotherapy Center

Zip code

569-8686

Address

Takatsuki city, Daigakutyo,2-7,Osaka

TEL

072-683-1221

Homepage URL


Email

masahiro.goto@ompu.ac.jp


Sponsor or person

Institute

Osaka Medical and Pharmaceutical College

Institute

Department

Personal name



Funding Source

Organization

Osaka Medical and Pharmaceutical College

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

Osaka Medical and Pharmaceutical College

Address

Takatsuki city, Daigakutyo,2-7,Osaka

Tel

072-683-1221

Email

rinri@osaka-med.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 04 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

0

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

Terminated

Date of protocol fixation

2021 Year 03 Month 01 Day

Date of IRB

2021 Year 04 Month 01 Day

Anticipated trial start date

2021 Year 04 Month 01 Day

Last follow-up date

2025 Year 03 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

2021 Year 03 Month 31 Day

Last modified on

2023 Year 10 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049984


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name