Objective To explore the effect of stanozolol combined with standardized anti-tumor therapy on the incidence of cachexia, body composition, systemic inflammation, and functional status in patients with advanced malignant tumors, as well as its safety. Methods A total of 60 patients with malignant tumors (TNM stage ⅢA or above) were selected as the research subjects and divided into either a control group or an observation group by a random number table, with 30 cases in each group. All patients received standardized anti-tumor therapy, based on which the observation group was additionally given oral stanozolol, with a total treatment course of 3 cycles (21 days per cycle). The primary outcome was the incidence of cachexia, and the secondary outcomes included body mass index (BMI), Karnofsky Performance Status (KPS) score, blood routine test results (hemoglobin, white blood cell count, platelet count), inflammatory indicators (C-reactive protein [CRP], interleukin-6 [IL-6]), nutrition and electrolyte indicators, and liver function (alanine aminotransferase [ALT], aspartate aminotransferase [AST]). Results The baseline characteristics of the two groups were balanced (all P>0.05). After treatment, the incidences of cachexia in the observation group and the control group were 0.00% (0/30) and 6.67% (2/30), respectively, with no statistically significant difference between the groups (P=0.492). The secondary outcomes showed that the BMI (［24.09±3.37］ kg/m² vs. ［22.24±3.74］ kg/m²), KPS score (73.52±3.25 vs. 69.25±3.51), and hemoglobin level (［116.88±16.82］ g/L vs. ［104.45±20.76］ g/L) in the observation group were better than those in the control group (all P<0.05). In terms of inflammatory indicators, the serum levels of CRP (29.54 [13.15, 45.11] mg/L vs. 59.35 [10.45, 68.77] mg/L) and IL-6 (［5.65±2.59］ pg/mL vs. ［11.77±1.12］ pg/mL) in the observation group were lower than those in the control group (all P<0.05). In addition, the serum sodium and chlorine levels in the observation group were slightly increased (all P<0.05), but there were no statistically significant differences in nutritional indicators such as albumin and prealbumin between the two groups (all P>0.05). Regarding safety, no clinically apparent adverse reactions were reported in either group. However, ALT and AST levels in the observation group increased compared to baseline (though remaining within normal range) and were higher than those in the control group (all P<0.05). Conclusion Combined use of stanozolol on the basis of standardized anti-tumor therapy does not significantly reduce the incidence of cachexia (possibly limited by the sample size), but it can effectively improve the BMI, functional status, and erythropoiesis of patients with advanced malignant tumors, and down-regulate inflammatory factors. The combined treatment has good safety in short-term application, but it is necessary to monitor electrolytes and liver function to prevent the risks of water-sodium retention and liver function damage.

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