Efficacy of Chinese medicine compound Fufang E’jiao Syrupfor symptom burden of cancer-related fatigue in patients with advanced cancer: A randomized clinical trial.

12070 Background: Cancer-related fatigue ( CRF) is often accompanied by a high symptom burden, significantly impacting the quality of life in patients with advanced cancer. Traditional Chinese medicine compound Fufang E’jiao Syrup (FFEJS) has shown promising potential in alleviating fatigue and reducing the overall burden of cancer-related symptoms. This study aims to investigate the efficacy and safety of FFEJS in reducing symptom burden in patients with advanced cancer. Methods: This multicenter, double-blinded, placebo-controlled trial was conducted across 29 hospitals in China and included 611 patients with advanced non-small cell lung cancer, colorectal cancer, or gastric cancer experiencing moderate-to-severe fatigue (Visual Analogue Fatigue Scale score ≥ 4). Participants were randomized to receive FFEJS (20 mL, 3 times daily) or placebo for six weeks. The primary outcome was the change in symptom burden, assessed via the Edmonton Symptom Assessment Scale (ESAS; score range 0-110, higher scores indicate greater burden). Secondary outcomes included changes in 11 individual symptoms (e.g., tiredness, depression, pain) and the incidence of adverse events. Linear mixed models were used for statistical analysis. Results: Among 611 patients randomized (303 received FFEJS and 308 received placebo; 210 [34.4%] had non-small cell lung cancer, 201 [32.9%] had colorectal cancer, and 200 [32.7%] had gastric cancer; mean [SD] age 62.8 [9.3] years; 413 [68.6%] male; mean [SD] baseline mean total symptom burden 38.96 [15.68] points, 503 (82.3%) completed the primary end point analysis. At week 6, FFEJS demonstrated a significantly greater reduction in total symptom burden compared to placebo (6.67 vs 3.16; adjusted mean difference: 3.51[95% CI 1.21–5.8]; P = .004). Patients in the FFEJS arm showed significant improvements in tiredness (1.68 vs 0.79; adjusted mean difference, 0.89 [95% CI, 0.62-1.18]; P < .001), drowsiness (1.13 vs 0.50; adjusted mean difference, 0.63 [95% CI, 0.32-0.95]; P < .001), pain (0.34 vs 0.01; adjusted mean difference, 0.33 [95% CI, 0.08-0.62]; P = .049), depression (0.41 vs -0.15; adjusted mean difference, 0.56 [95% CI, 0.28-0.86]; P = .003) compared with the placebo arm. Subgroup analysis revealed greater symptom reduction in geriatric patients (≥ 60 years; P < .001) and in non-small cell lung ( P = .044) and colorectal cancer ( P = .047), compared to gastric cancer ( P = .123). Conclusions: FFEJS significantly reduced total symptom burden and improved fatigue-related symptoms in patients with advanced cancer. Subgroup analysis highlighted enhanced efficacy in geriatric populations and certain cancer types. These results highlight the potential of FFEJS as a valuable integrative therapy for improving symptom management and quality of life in advanced cancer care. Clinical trial information: NCT04147312 .