Cardioprotective effect of crocin in patients with breast cancer receiving anthracycline-based chemotherapy: A randomized, double-blind, placebo-controlled study

Anthracycline chemotherapy leads to cardiotoxicity in patients with breast cancer. We performed a double-blind randomized controlled trial to assess the efficacy of crocin (crocin tablets) in reducing anthracycline-induced cardiotoxicity in breast cancer patients. Eligible patients were randomly ass...

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Main Authors: Xinye Li, Xin Su, Wanping Liang, Li Wang, Chao Yuan, Juping Xu, Yijun Zhang, Yan Liu, Ning Ma, Fan Yang, Yiyuan Yang, Liyuan Tao, Shipeng Sun, Hongcai Shang, Yanwei Xing
Format: Article
Language:English
Published: Elsevier 2025-03-01
Series:Pharmacological Research
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Online Access:http://www.sciencedirect.com/science/article/pii/S1043661825000556
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Summary:Anthracycline chemotherapy leads to cardiotoxicity in patients with breast cancer. We performed a double-blind randomized controlled trial to assess the efficacy of crocin (crocin tablets) in reducing anthracycline-induced cardiotoxicity in breast cancer patients. Eligible patients were randomly assigned to receive either treatment with crocin tablets or placebo for 6 months. Primary efficacy outcome was the proportion of patients with a drop in left ventricular ejection fraction (LVEF) of at least 10 % from baseline until 6 months. We randomized 200 patients; 7 of them had no valid randomization as the change in chemotherapy scheme. A total of 193 eligible participants (mean [SD] age, 50.9 [9.6] years; all women) were randomly assigned to receive crocin tablets or placebo. The incidence of the primary efficacy outcome was 7.2 % (7/97) in the crocin group and 17.7 % (17/96) in the placebo group (P = 0.027). At 6 months, there were significant differences in the mean change of N-terminal pro–brain natriuretic peptide (NT-pro BNP) between the groups (3.06 [-25.18–6.95] vs. 3.06 [-4.85–24.98] pg/ml; P = 0.017). The changes in heart rate from baseline to 6 months showed a significant difference as the mean difference of −4.00 (95 %CI, −6.95 to −1.05) bpm (P = 0.008). Conclusively, among patients with breast cancer treated with anthracycline-based chemotherapy, crocin tablets reduced the incidence of LVEF reduction. This finding indicated that crocin tablets might be a safe and effective therapy to prevent the cardiotoxicity in this population. (Chictr.org.cn, ID Number: ChiCTR2000041134).
ISSN:1096-1186