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
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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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author 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
author_facet 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
author_sort Xinye Li
collection DOAJ
description 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).
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language English
publishDate 2025-03-01
publisher Elsevier
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series Pharmacological Research
spelling doaj-art-8d0771d506fd4f4894eae161ce9e3fe62025-02-06T05:11:05ZengElsevierPharmacological Research1096-11862025-03-01213107630Cardioprotective effect of crocin in patients with breast cancer receiving anthracycline-based chemotherapy: A randomized, double-blind, placebo-controlled studyXinye Li0Xin Su1Wanping Liang2Li Wang3Chao Yuan4Juping Xu5Yijun Zhang6Yan Liu7Ning Ma8Fan Yang9Yiyuan Yang10Liyuan Tao11Shipeng Sun12Hongcai Shang13Yanwei Xing14Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China; Beijing University of Chinese Medicine, Beijing, ChinaSun Yat-sen University Cancer Center, State Key Laboratory of Oncology in SouthChina, Guangdong Provincial Clinical Research Center for Cancer, Guangzhou, ChinaThe First Affiliated Hospital, Hebei North University, Zhangjiakou, ChinaXingtai People’s Hospital, Xingtai, ChinaDezhou Second People’s Hospital, Dezhou, ChinaJiaozuo Second People’s Hospital, Jiaozuo, ChinaThe First Affiliated Hospital, Hebei North University, Zhangjiakou, ChinaJiaozuo Second People’s Hospital, Jiaozuo, ChinaDezhou Second People’s Hospital, Dezhou, ChinaGuang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, ChinaGuang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, ChinaClinical Epidemiology Research Center of the Third Hospital of Peking University, Beijing, ChinaGuang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, ChinaDongfang Hospital, Beijing University of Chinese Medicine, Beijing, China; Corresponding authors.Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China; Corresponding authors.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).http://www.sciencedirect.com/science/article/pii/S1043661825000556Breast cancerAnthracyclineCrocinCardioprotectiveLeft ventricular ejection fraction
spellingShingle 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
Cardioprotective effect of crocin in patients with breast cancer receiving anthracycline-based chemotherapy: A randomized, double-blind, placebo-controlled study
Pharmacological Research
Breast cancer
Anthracycline
Crocin
Cardioprotective
Left ventricular ejection fraction
title Cardioprotective effect of crocin in patients with breast cancer receiving anthracycline-based chemotherapy: A randomized, double-blind, placebo-controlled study
title_full Cardioprotective effect of crocin in patients with breast cancer receiving anthracycline-based chemotherapy: A randomized, double-blind, placebo-controlled study
title_fullStr Cardioprotective effect of crocin in patients with breast cancer receiving anthracycline-based chemotherapy: A randomized, double-blind, placebo-controlled study
title_full_unstemmed Cardioprotective effect of crocin in patients with breast cancer receiving anthracycline-based chemotherapy: A randomized, double-blind, placebo-controlled study
title_short Cardioprotective effect of crocin in patients with breast cancer receiving anthracycline-based chemotherapy: A randomized, double-blind, placebo-controlled study
title_sort cardioprotective effect of crocin in patients with breast cancer receiving anthracycline based chemotherapy a randomized double blind placebo controlled study
topic Breast cancer
Anthracycline
Crocin
Cardioprotective
Left ventricular ejection fraction
url http://www.sciencedirect.com/science/article/pii/S1043661825000556
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