Effects of early nutritional interventions in patients with cancer receiving palliative chemotherapy in an outpatient setting: protocol for the NICOS intervention study

Cancer-related malnutrition affects 30–50% of patients and is associated with increased treatment toxicity, reduced quality of life (QoL), impaired physical function, and decreased survival. Despite its clinical significance, malnutrition remains underrecognised and undertreated, especially in patients receiving palliative chemotherapy. Evidence on early, individualised nutritional interventions in this population is limited. The purpose of the study is to evaluate the effect of early, individualised targeted nutritional treatment on body weight, QoL, treatment tolerance, survival, muscle mass and physical function compared with standard care. The Effects of early Nutritional Interventions in patients with Cancer receiving palliative chemotherapy in an Outpatient Setting study (NICOS) is a prospective, non-randomised 24-week intervention study conducted at a Danish oncology outpatient clinic. It includes 196 adult patients with lung, colorectal, ovarian or pancreatic cancer receiving palliative chemotherapy (intervention group: n = 98; historical control group: n = 98). The intervention group receives early individualised targeted nutritional treatment delivered by clinical dietitians, initiated at their first chemotherapy treatment, while a historical control group received standard care prior to the intervention. The primary outcome is the difference in body weight development between the two groups over the 24-week study period. Secondary outcomes include QoL, treatment tolerance, survival, muscle mass, and physical function. Data is collected at baseline, 12 weeks, and 24 weeks. Analyses will be adjusted for relevant potential confounding factors. NICOS aims to address a gap in evidence by evaluating the effect of early individualised targeted nutritional treatment during palliative chemotherapy, a context where nutritional treatment is often underrecognised and inconsistently delivered. By using a pragmatic, non-randomised design with a historical control group receiving standard care, the study reflects real-world clinical practice while minimising contamination of standard care. The findings are expected to inform future integration of structured nutritional treatment into standard palliative oncology care pathways.