The Effect of Immunonutrition and Chemotherapy-Induced Neutropenia in Advanced Gastrointestinal Cancer Receiving Palliative Chemotherapy, A Pilot Randomized Controlled Trial

Abstract

Abstract Background: Malnutrition affects individual health status and impacts the response to chemotherapy in cancer patients. Furthermore, chemotherapy may worsen the nutritional status in these patients and vice versa. Therefore, oral nutrition supplements (ONS), either standard or special formula, have been recommended by several guidelines in these settings. Immunonutrition formulas theoretically provide a better anticachectic, anti-inflammatory and anti-tumor effect to a regular diet or standard formula. Objective: To compare the effect of ONS with immunonutrients and standard ONS on grade II-IV neutropenia in gastrointestinal (GI) cancer that has received palliative chemotherapy. Methods: We conducted a single-center, double-blind, prospective controlled trial in patients with advanced GI cancer who received palliative chemotherapy. Patients were randomized into two groups, ONS with immunonutrients (ONS-IM) and standard ONS formula (ONS-SF) with 500 kcal/day. The primary endpoint was the incidence of neutropenia grade II-IV. Furthermore, body weight, body composition, PG-SGA (Patient-Generated Subjective Global Assessment) scores, dietary intake, inflammatory parameters, and treatment toxicities were evaluated at baseline and 12 weeks after chemotherapy between two groups. Results: A total of 50 patients were included (24 vs 26 in the ONS-IM vs. the ONS-SF, respectively). All patients were diagnosed with colorectal cancer, 24(48%) were men, with a mean age of 65.8 years (IQR 34-84). PG-SGA ≥9 was 60%, 46% had ≥ 2 organ metastases and 54% received first-line chemotherapy. There were no statistical differences in the baseline characteristics between the two groups. Neutropenia grade II-IV occurred less frequently in the ONS-IM group compared to the ONS-SF group (16.7% vs 42.3%, P =0.067), especially in subgroup of patients who received either ONS-IM or ONS-SF more than 70% (14.3% vs 45.8%, P=0.028). The mean differences in the PG-SGA score were significantly better in the ONS-IM compared to ONS-SF group (6.7; 95%CI:5.35,8.14 vs 4.72; 95%CI:3.09,6.35, P=0.05). Body fat mass and the percentage of CD3 count were improved significantly in the ONS-IM group compared to the ONS-SF group. There was no difference in other inflammatory markers between the two groups. Conclusions: Patients who were supplemented with immunonutrition demonstrated a decrease in grade II-IV neutropenia, improved PG-SGA scores, body fat mass and the percentage of CD3 counts.