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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000043792
Enrollment
40
Registered
2021-04-01
Start date
2021-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Interventions

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. Standard treatment without Ninjin-Yoei-T

Sponsors

Osaka Medical and Pharmaceutical College
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Difference in time to onset of cachexia

Countries

Japan

Contacts

Public ContactMasahiro Goto

Osaka Medical and Pharmaceutical College Cancer Chemotherapy Center

masahiro.goto@ompu.ac.jp072-683-1221

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026