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A randomized controlled clinical study on the application of immunonutrition (Sumansin) in the perioperative and long-term management of patients with colorectal cancer undergoing surgery

A randomized controlled clinical study on the application of immunonutrition (Sumansin) in the perioperative and long-term management of patients with colorectal cancer undergoing surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071078
Enrollment
Unknown
Registered
2023-05-04
Start date
2023-04-20
Completion date
Unknown
Last updated
2023-06-04

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 : Total nutritional formula Food for cancer patients for Special medical Use (IMPACT ORAL)

Sponsors

Cancer Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age above 18 years old, under 75 years old, regardless of gender; 2. Patients diagnosed with colorectal adenocarcinoma by histology or cytology and undergoing radical surgery; 3. Body mass index (BMI) 18.5-28kg/m2 (including 18.5 and 28kg/m2); 4. Patients who could tolerate enteral nutrition after discharge; 5. Life expectancy over 3 months; 6. Hemoglobin =90g/L at discharge; 7. Albumin =2.5g/dL at discharge; 8. Patients can give informed consent, agree to participate in the study and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. There are serious clinical symptoms, underlying diseases or surgical complications, such as gastrointestinal bleeding and anastomotic fistula, which may jeopardize the development and follow-up of the study; 2. Previous history of gastrointestinal surgery or other digestive tract treatments that affect nutrient absorption; 3. The patient is a pregnant or lactating woman; 4. The patients underwent minor operations for gastrointestinal tumors such as confirmatory biopsy or endoscopy, or underwent endoscopic tumor resection; 5. Nutrition should not be ingested orally or through tube feeding before the operation; 6. The patient had participated in another interventional clinical study, including one related to nutritional support, within 4 weeks prior to enrollment; 7. Malignant neoplasms in the past 5 years (other than basal cell skin neoplasms in situ, which were successfully treated, and cervical neoplasms in situ); 8. The patient had abnormal liver and kidney function (ALT=2 times the upper limit of normal value; Total bilirubin Tbil=2 times the upper limit of normal value; Creatinine Cr=2 times the upper limit of normal); 9. Known to have uncontrolled diabetes mellitus or fasting blood glucose =10mmol/L; 10. The patient has a known history of hypothyroidism or hyperthyroidism; 11. The patient is using biologic agents containing thymosin, glucocorticoid, thyroxin, growth hormone, anti-tumor necrosis factor, etc.; 12. A known history of allergy to any component of the study product; 13. Patients or family members refuse to sign informed consent; 14. Uncontrolled mental illness. 15. Patients deemed unsuitable for this study by the researcher (such as poor compliance, etc.)

Design outcomes

Primary

MeasureTime frame
Serum prealbumin;

Secondary

MeasureTime frame
Body weight;Fat loss weight, limb skeletal muscle index;Inflammation-related indicators;Immune-related indicators;Metabolism-related index;

Countries

China

Contacts

Public ContactWang Xishan

Cancer Hospital, Chinese Academy of Medical Sciences

13250510307@163.com+86 13552367779

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 25, 2026