Efficacy of treatment with traditional Chinese medicine (Renshen Yangrong Tang granules) for cancer-related fatigue in patients with platinum-based chemotherapy: A randomized, double- blinded, placebo-controlled, multicenter trial.

12012 Background: Although there is higher incidence of cancer-related fatigue (CRF) in patients undergoing chemotherapy, effective drugs is still in need. Renshen Yangrong Tang (RSYRT), a Traditional Chinese Medicine, has shown promise in alleviating CRF. This trial aims to investigate whether RSYRT could reduce fatigue and improve quality of life in cancer patients with platinum-based chemotherapy. Methods: This prospective, multicenter, double-blinded, placebo-controlled trial was implemented at 4 centers in China, enrolling 192 platinum-treated cancer patients with Visual Analogue Scale for Fatigue ≥4 points on the 10th day of the first cycle of chemotherapy. Participants were randomized to receive RSYRT (10.35g, 2 times per day) or a matching placebo orally simultaneously with chemotherapy from C1D10 to C2D10. The study was conducted between April, 2020 and September,2023, with a final follow-up on October,2023. The primary outcome was the change in total mean score (range: 0[no fatigue] to 10[extreme fatigue] points) on the Brief Fatigue Inventory(BFI-C) from baseline to week 3. Secondary outcomes include quality of life(European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire C30, QLQ-C30), fatigue score (MD Anderson Symptom Inventory for Traditional Chinese Medicine MDASI-TCM) and adverse events. RSYRT were compared with the placebo group using a linear mixed model. Results: Among 192 patients randomized, 163 participants completed assessment (RSYRT:81 and Placebo:82). There was no significant differences of “Usual fatigue in last 24 hours" score (RSYRT:5.15±1.41 vs Placebo:5.40±1.44, P = 0.256) in BFI between two groups at baseline. By the end of week 3, the RSYRT group achieved normal fatigue levels compared to the placebo group (RSYRT: 3.35±1.95 vs Placebo: 4.15±2.12, P = 0.013). The overall health status of QLQ-C30 also showed statistically significant differences (Pre intervention [RSYRT: 52.78 ± 15.14 vs. placebo: 49.49 ± 17.63, P = 0.204]，After intervention [RSYRT: 65.53 ± 15.52 vs. placebo: 57.72 ± 19.98, P = 0.006]）. The fatigue score of MDASI-TCM was comparable at baseline (RSYRT: 5.72 ± 1.69 vs placebo: 5.90 ± 1.70, P = 0.483），and a significant decrease was observed in the third week (RSYRT: 3.69 ± 2.05 vs placebo: 4.56 ± 2.30, P = 0.012）. There was no difference in adverse events occurrence between RSYRT and the placebo groups. Conclusions: In this randomized clinical trial among platinum-treated cancer patients with CRF, RSYRT reduced fatigue severity and improved quality of life compared to placebo. Clinical trial information: NCT05229029 .