A Randomized Trial of Long-term Immunonutrition Oral Supplements Versus Standard Nutrition in Patients who Underwent Colorectal Cancer Surgery after Discharge: Interim Analysis of a Nationwide Multicentre Study in China

Background Enteral nutrition (EN) can prevent and treat postoperative malnutrition in patients with malignant tumors, thereby improving their short-term postoperative prognosis. However, there is currently a lack of long-term observational data on the impact of immunonutrition (IMN) on the immunotrophic status of patients with colorectal cancer (CRC) after discharge. Methods This was a multicentre, randomized, controlled noninferiority trial with two parallel intervention arms for patients with CRC (ChiCTR2300071078). Patients were included as study participants after screening. They were randomly assigned to receive an immunomodulatory oral formula (IMN group) or a standard nutritional oral formula (SN group). The ratio of the number of enrolled patients in the IMN and SN groups was 2:1. After the intervention, changes in nutritional and immunologic parameters, such as body mass index (BMI), patient-generated subjective global assessment (PG-SGA), transferrin (TFN), albumin (ALB), prealbumin (PA), glucose (GLU), lymphocyte absolute value (LAV), C-reactive protein (CRP), immunoglobulin G (IgG), IgM, and IgA, were the primary endpoints of the study. The secondary end points were the postoperative complications, including total, infectious and noninfectious complications. Results Interim data analysis is presented in this report. There were 416 patients enrolled from the main centre. Of these, 279 patients were in the IMN group, and 137 patients were in the control group. The patients in the two groups had similar demographics. With respect to nutritional parameters, after the intervention, the PG-SGA and serum ALB significantly differed between the two groups (P < 0.05). Moreover, compared with those in the control group, the LAV, IgG, and IgM in the IMN group were significantly increased after the intervention. Finally, although the incidence of postoperative infectious complications in the IMN group was lower than that in the SN group, there was no significant difference in the rate of postoperative total, infectious, or noninfectious complications between the two groups (P > 0.05). Conclusions Interim data show that long-term, continuous oral IMN after discharge can improve the nutritional status, enhance the immune response, and reduce the incidence of postoperative infectious complications in patients with CRC who have undergone radical surgery.