Effects of FSMP on nutrition status and sarcopenia among nutritional risk cancer patients: A randomized, double-blind, placebo-controlled study.

Background and objectives: Cancer patients at nutritional risk have a worse prognosis, but this can be improved by nutritional support. Food for special medical purposes (FSMP), as a new form of nutritional support, needs to be further evaluated for its safety and efficacy in these patients. Our study elucidate the impact of FSMP on nutritional status and sarcopenia among nutritional risk cancer outpatients by assessing the NRS2002 score, exercise performance, muscle mass, and inflammatory factors pre- and postintervention.

Methods and study design: We conducted a single-centre, double-blind, randomized controlled interventional study. Patients from the oncology clinic with nutritional risk were randomly allocated to the control group or the FSMP group and received oral intervention for 8 weeks. The primary outcome was improvement in nutritional risk, while the secondary outcomes were improvements in sarcopenia prevalence and physical performance indicators. Other outcomes included alterations in calf circumference, hsCRP, 25(OH)VD3, Alb. etc. A linear mixed-effects model was used to compare the prepost-intervention changes in these results.

Results: Thirty-six cancer patients were included, 25 completed the study. The percentage of patients at nutritional risk after intervention in the FSMP group was significantly lower than the control group (Χ2=4.186, p=0.041). The FSMP group demonstrated significant improvements in the TUG test, gait speed, grip strength, and upper-limb muscle mass. However, there was no significant improvement in the rate of sarcopenia. Moreover, calf circumference, hsCRP, 25(OH)VD3, Alb exhibited no significant changes.

Conclusions: FSMP can effectively improve the nutritional status, physical performance and upper-limb muscle mass of cancer patients.