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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
