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Nuobaoneng special clinical use formula (tumor nutritional formula) clinical safety, nutritional adequacy and clinical effects of special medical use randomized controlled multicenter trial

Nuobaoneng clinical efficacy, nutritional adequacy and clinical effects of special medical use formulas (tumor nutritional formula)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026003
Enrollment
Unknown
Registered
2019-09-17
Start date
2018-09-01
Completion date
Unknown
Last updated
2019-09-30

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

Conditions

Malnourished tumor patients

Interventions

Group 1:feeding Nuobaoneng powder
Group 2:feeding Ruineng TPF-T

Sponsors

Beijing Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Subjects were diagnosed as malignant tumors by pathology or cytology within 8 weeks prior to enrollment. Patients, including cachexia, anorexia, chewing and dysphagia; 2. According to the investigator's judgment, patients requiring nutritional therapy: (NRS2002 total score >=3 points or PG-SGA >=4 points or estimated to be unable to eat 60% of the recommended energy intake for more than one week); 3. Subjects are laboratory tested and meet the following criteria: (1) blood routine: hemoglobin >=90g/L, absolute neutrophil count (ANC >=1.5x10^9/L, platelets >=100x10^9/L; (2) liver and kidney function: ALT, AST =30g / L; 4. Ages over 10 years old, male and female and ethnic groups are not limited; 5. Expected survival period >=3 months; 6. Those who voluntarily participate in clinical trials and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who do not require artificial nutritional support; 2. Patients who have undergone parenteral nutrition at the same time; 3. All patients who are not suitable for enteral nutrition, such as patients with digestive tract spasm, gastrointestinal bleeding, complete intestinal obstruction, severe diarrhea and other patients with severe digestive dysfunction; 4. Patients who are unable to meet the prescribed doses as required, such as postoperative, radiotherapy, chemotherapy, and patients with severe nausea and vomiting; 5. Severe liver and kidney dysfunction; 6. Patients using coumarin anticoagulants and immunological preparations; 7. Those who have been receiving systemic steroids for a long time (Note: short-term user withdrawal > 2 weeks can be selected); 8. Patients who have taken fish oil (pure fish oil products) within 4 weeks or participated in other clinical trials; 9. Drugs (such as glucocorticoids, etc.) that the investigator believes may affect the therapeutic effect; 10. Patients with other serious organ diseases; 11. Combine people with poorly controlled endocrine, metabolic and immune system diseases; 12. Those who have congenital metabolic disorders and substances allergic to the known ingredients of the test food for the substances contained in this product; 13. Women who are pregnant or preparing for pregnancy, lactating women; 14. Patients with poor adherence or who the investigator believes are not suitable for the study.

Design outcomes

Primary

MeasureTime frame
Lean body mass;

Secondary

MeasureTime frame
Grip strength, protein, nutrient intake;

Countries

China

Contacts

Public ContactFang Yu

Beijing Cancer Hospital

yzkchun@126.com+86 18612081247

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026