Skip to content

A study of immune-enhanced oral nutritional supplementation based on targeted nutritional strategies in postoperative chemotherapy for colorectal cancer

A study of immune-enhanced oral nutritional supplementation based on targeted nutritional strategies in postoperative chemotherapy for colorectal cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100601
Enrollment
Unknown
Registered
2025-04-11
Start date
2025-04-21
Completion date
Unknown
Last updated
2025-04-14

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

Conditions

colorectal cancer

Interventions

Experimental group:ONS supplement with immunonutrients 400kcal while receiving dietary advice
Control group:The control group received dietary advice along with an isocaloric ONS supplement without immunonutrient formulation 400kcal

Sponsors

Lu'an People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1). 18 years old =3 or are not expected to be able to meet the recommended energy intake with oral intake; (4). Subjects with laboratory tests that meet the following criteria: 1) routine blood: haemoglobin >= 80g/L; 2) albumin >= 2.5g/dL; (5). Body mass index (BMI) = 3 months; (8). Those who participate voluntarily and sign an informed consent form.

Exclusion criteria

Exclusion criteria: (1). No artificial nutritional support is required; (2). Simultaneous parenteral nutrition; (3). All patients who are not suitable for enteral nutrition, such as gastrointestinal fistula, active bleeding in the gastrointestinal tract, complete intestinal obstruction, severe diarrhoea and other serious digestive and absorption dysfunction; (4). Patients with severe hepatic and renal insufficiency (alanine aminotransferase >=2.5 times the upper limit of normal value; total bilirubin >=1.5 times the upper limit of normal value; creatinine >=1.5 times the upper limit of normal value); (5). Subjects with confirmed diabetes mellitus; (6). Subjects are using fatty milk containing Omega-3 fatty acids, glutamine, glucocorticoids, thyroxine (except for those who have been taking it for more than 3 months), growth hormone, and anti-tumour necrosis factor biologics; (7). Participation in other interventional clinical trials (including drugs, nutritional preparations, medical devices, etc.) within 4 weeks prior to enrolment; (8). Combination of other serious clinical conditions or comorbidities that may jeopardise study conduct and follow-up; (9). Uncontrolled mental illness; (10). Pregnant women, women preparing for pregnancy and their partners, and nursing mothers; (11). Subjects with poor compliance or who, in the opinion of the investigator, are unsuitable for participation in this trial.

Design outcomes

Primary

MeasureTime frame
body mass index (BMI);albumin;lymphocyte count;white cell count;Skeletal muscle content;grip strength;SF-12 Quality of Life Scale;Neutrophil granulocyte count;

Secondary

MeasureTime frame
total protein;haemoglobin;cholesterol;triglyceride;

Countries

China

Contacts

Public ContactXiaoyang Jiang

Lu'an People's Hospital

798261984@qq.com+86 187 1552 5188

Outcome results

None listed

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