Skip to content

Evaluation of the use of a Food for Special Medical Purpose in patients with oncology

A Randomized, Open, Positively Controlled Multicenter Clinical Study to Evaluate the Use of Kangqili, a Foods for Special Medical Purposes in the Adjuvant Treatment of Oncology Patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107598
Enrollment
Unknown
Registered
2025-08-14
Start date
2022-10-14
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

patients with oncology

Interventions

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.No gender restrictions; 2.Age >=18 and =3, or PG-SGA score >=4, or Expected inability to achieve >=60% of recommended oral intake for >1 week; 5.Hepatic and renal function: ALT/AST <=2.5×ULN (<=5×ULN for liver metastasis) ALP <=2.5×ULN (<=5×ULN for liver metastasis) Total bilirubin (TBIL) <1.5×ULN Serum creatinine (SCr) <1.5×ULN Triglycerides (TG) <1.5×ULN[(Note: ULN = upper limit of normal)]; 6.Tolerable to enteral nutrition; 7.Willing to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1.Intolerance or inability to receive oral/enteral tube feeding; 2.Conditions severely affecting digestion/absorption of study products: Acute pancreatitis Gastrointestinal failure Complete intestinal obstruction Active gastrointestinal bleeding Severe diarrhea or other malabsorption disorders; 3.Current use of other nutritional preparations that may interfere with study outcomes; 4.Comorbid major organ dysfunction, multiple organ failure, or severe metabolic disorders; 5.Cancer cachexia patients; 6.Pregnant/lactating women or women of childbearing potential with positive baseline pregnancy test; 7.Known allergy to any component of the investigational product; 8.Investigator's judgment of unsuitability for participation;

Design outcomes

Primary

MeasureTime frame
prealbumin;weight;

Secondary

MeasureTime frame
Gastrointestinal reactions;liver and kidney function;handgrip;walking speed;

Countries

China

Contacts

Public ContactYu Kang

Peking Union Medical College Hospital

yuk1997@sina.com+86 10 69155550

Outcome results

None listed

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