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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043792
Receipt No. 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 2021/03/31

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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 College
Division name Second Department of Internal Medicine
Zip code 569-8686
Address Takatsuki city, Daigakutyo,2-7,Osaka
TEL 072-683-1221
Email higuchi@osaka-med.ac.jp

Public contact
Name of contact person
1st name Fukutaro
Middle name
Last name Shimamoto
Organization Osaka Medical College
Division name Cancer Chemotherapy Center
Zip code 569-8686
Address Takatsuki city, Daigakutyo,2-7,Osaka
TEL 072-683-1221
Homepage URL
Email shimamotof@osaka-med.ac.jp

Sponsor
Institute Osaka Medical College
Institute
Department

Funding Source
Organization Osaka Medical 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 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
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 03 Month 01 Day
Date of IRB
Anticipated trial start date
2021 Year 04 Month 01 Day
Last follow-up date
2023 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
2021 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.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


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