Effects of high-protein nutritional supplementation on nutritional status, physical function, and quality of life in older gastric cancer patients receiving neoadjuvant chemotherapy: a randomized trial

Objectives: This study aimed to evaluate the effects of high-protein oral nutritional supplements (ONS) on nutritional status, physical function, and quality of life in older gastric cancer patients undergoing neoadjuvant chemotherapy (NAC). Methods: A prospective, randomized controlled trial was conducted between February 2023 and February 2024, including 46 patients aged 65 or older with newly diagnosed, locally advanced gastric cancer. Participants were randomized into two groups: an intervention group receiving high-protein ONS in addition to standard nutrition care, and a control group receiving only standard nutrition care. Nutritional status was assessed using the Mini Nutritional Assessment (MNA), physical function was evaluated through handgrip strength, Activities of Daily Living (ADL), and Instrumental Activities of Daily Living (IADL) scales, and health-related quality of life was measured using the EORTC QLQ-C30. Bioelectrical impedance was used to analyze body composition. Results: Among the 46 patients (23 in each group), baseline characteristics were similar between the groups (p > 0.05). The ONS group showed significantly higher energy and protein intake than the control group (p < 0.05). MNA scores improved significantly in the ONS group after 8 weeks (p < 0.001), with a reduction in malnutrition risk to 4.3%, compared to 17.4% in the control group (p = 0.003). ADL and IADL scores remained stable in both groups, and both groups reduced functions and increased symptoms of HRQL over 8 weeks. Emotional functioning scores significantly declined in both groups over the 8-week period (ONS group: from 91.7 [16.67] to 83.3 [8.33], p = 0.001; non-ONS group: from 91.7 [8.33] to 83.3 [16.67], p = 0.011). Fatigue levels also increased markedly in both groups (ONS: from 11.1 [11.11] to 49.3 ± 17.02; non-ONS: from 22.2 [11.11] to 44.4 [22.22], p < 0.001). Additionally, constipation symptoms worsened significantly in the non-ONS group by week 8 (p = 0.008). Conclusions: High-protein ONS improved nutritional status and reduced malnutrition risk in older gastric cancer patients undergoing NAC. Further research is needed to assess the long-term effects of ONS on physical function and quality of life. Trial registration: Registered under ClinicalTrials.gov Identifier no. NCT06645912. © The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature 2025.