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...
Saved in:
Main Authors: | , , , , , , , , , , , , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
Elsevier
2025-03-01
|
Series: | Pharmacological Research |
Subjects: | |
Online Access: | http://www.sciencedirect.com/science/article/pii/S1043661825000556 |
Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
_version_ | 1832087774337957888 |
---|---|
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). |
format | Article |
id | doaj-art-8d0771d506fd4f4894eae161ce9e3fe6 |
institution | Kabale University |
issn | 1096-1186 |
language | English |
publishDate | 2025-03-01 |
publisher | Elsevier |
record_format | Article |
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 |
work_keys_str_mv | AT xinyeli cardioprotectiveeffectofcrocininpatientswithbreastcancerreceivinganthracyclinebasedchemotherapyarandomizeddoubleblindplacebocontrolledstudy AT xinsu cardioprotectiveeffectofcrocininpatientswithbreastcancerreceivinganthracyclinebasedchemotherapyarandomizeddoubleblindplacebocontrolledstudy AT wanpingliang cardioprotectiveeffectofcrocininpatientswithbreastcancerreceivinganthracyclinebasedchemotherapyarandomizeddoubleblindplacebocontrolledstudy AT liwang cardioprotectiveeffectofcrocininpatientswithbreastcancerreceivinganthracyclinebasedchemotherapyarandomizeddoubleblindplacebocontrolledstudy AT chaoyuan cardioprotectiveeffectofcrocininpatientswithbreastcancerreceivinganthracyclinebasedchemotherapyarandomizeddoubleblindplacebocontrolledstudy AT jupingxu cardioprotectiveeffectofcrocininpatientswithbreastcancerreceivinganthracyclinebasedchemotherapyarandomizeddoubleblindplacebocontrolledstudy AT yijunzhang cardioprotectiveeffectofcrocininpatientswithbreastcancerreceivinganthracyclinebasedchemotherapyarandomizeddoubleblindplacebocontrolledstudy AT yanliu cardioprotectiveeffectofcrocininpatientswithbreastcancerreceivinganthracyclinebasedchemotherapyarandomizeddoubleblindplacebocontrolledstudy AT ningma cardioprotectiveeffectofcrocininpatientswithbreastcancerreceivinganthracyclinebasedchemotherapyarandomizeddoubleblindplacebocontrolledstudy AT fanyang cardioprotectiveeffectofcrocininpatientswithbreastcancerreceivinganthracyclinebasedchemotherapyarandomizeddoubleblindplacebocontrolledstudy AT yiyuanyang cardioprotectiveeffectofcrocininpatientswithbreastcancerreceivinganthracyclinebasedchemotherapyarandomizeddoubleblindplacebocontrolledstudy AT liyuantao cardioprotectiveeffectofcrocininpatientswithbreastcancerreceivinganthracyclinebasedchemotherapyarandomizeddoubleblindplacebocontrolledstudy AT shipengsun cardioprotectiveeffectofcrocininpatientswithbreastcancerreceivinganthracyclinebasedchemotherapyarandomizeddoubleblindplacebocontrolledstudy AT hongcaishang cardioprotectiveeffectofcrocininpatientswithbreastcancerreceivinganthracyclinebasedchemotherapyarandomizeddoubleblindplacebocontrolledstudy AT yanweixing cardioprotectiveeffectofcrocininpatientswithbreastcancerreceivinganthracyclinebasedchemotherapyarandomizeddoubleblindplacebocontrolledstudy |