Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on sleep in brain health

LIVE: Thursday 2nd May 2024, 18:00-19:30 (CEST)

Quality sleep is essential for health. But what happens to our brains when sleep patterns are disturbed? Join our experts to explore the interplay between sleep disruption and neurological diseases, and the questions that you need to be asking your patients to help you prevent the harmful effects of sleep deprivation.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

Cardioprotective effect of Platycodon grandiflorum in patients with early breast cancer receiving anthracycline-based chemotherapy: study protocol for a randomized controlled trial

Authors: Wei Hao, Sheng Liu, Yuenong Qin, Chenping Sun, Liying Chen, Chunyu Wu, Yijia Bao

Published in: Trials | Issue 1/2017

Login to get access

Abstract

Background

Anthracyclines, alone or in combination with other drugs, are among the most effective chemotherapeutic agents to treat breast cancer both in the adjuvant and neoadjuvant setting. Unfortunately, anthracycline-associated dose-dependent cardiotoxicity is a limiting factor in clinical use. Extensive efforts have been devoted to identifying strategies to prevent anthracycline-induced cardiotoxicity. However, most cardioprotective agents have shown little effect in clinical trials. Herbal medicines are pure, natural substances that have been used for centuries in many countries, including China. This trial aims to evaluate the cardioprotective effects and safety of Platycodon grandiflorum granules compared to placebo granules in patients with early breast cancer receiving anthracycline-based chemotherapy.

Method/design

This study is a single-center, double-blinded, randomized, placebo-controlled, parallel-group trial. A total of 120 patients will be randomly allocated in a 1:1 ratio to receive either P. grandiflorum granules or placebo granules twice daily for 12 weeks. The primary outcome is heart failure (either clinical or subclinical). The secondary outcomes include all-cause mortality, cardiac death, electrocardiogram (ECG) findings, left ventricular diastolic function, longitudinal systolic strain and velocities measured by tissue Doppler imaging, cardiac biomarkers, such as troponin I (TnI), brain natriuretic peptide (BNP), and creatine kinase isoenzymes (CK-MB). Assessments will be performed at baseline (before randomization) and 3, 6, 9, 12, 16, and 20 weeks after randomization.

Discussion

This will be the first clinical trial to evaluate the cardioprotective effects and safety of P. grandiflorum in patients with early breast cancer receiving anthracycline-based chemotherapy. We are also performing this trial to assess the feasibility of a larger-scale clinical trial in the future.

Trail registration

Chinese Clinical Trial Registry, ChiCTR-IPR-16009256. Registered on 23 September 2016.
Appendix
Available only for authorised users
Literature
1.
Lefrak EA, Pitha J, Rosenheim S, et al. A clinicopathologic analysis of adriamycin cardiotoxicity. Cancer. 1973;32:302–14.CrossRefPubMed
2.
Early Breast Cancer Trialists’ Collaborative Group (EBCTCG). Effect of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005;365:1687–717.CrossRef
3.
Von Hoff DD, Layard MW, Basa P, et al. Risk factors for doxorubicin-induced congestive heart failure. Ann Intern Med. 1979;91:710–7.CrossRef
4.
Tan C, Tasaka H, Yu KP, et al. Daunomycin, an antitumor antibiotic, in the treatment of neoplastic disease. Clinical evaluation with special reference to childhood leukemia. Cancer. 1967;20:333–53.CrossRefPubMed
5.
Acar Z, Kale A, Turgut M, et al. Efficiency of atorvastatin in the protection of anthracycline-induced cardiomyopathy. J Am Coll Cardiol. 2011;58(9):988–9.CrossRefPubMed
6.
Kalay N, Basar E, Ozdogru I, et al. Protective effects of carvedilol against anthracycline-induced cardiomyopathy. J Am Coll Cardiol. 2006;48:2258–62.CrossRefPubMed
7.
Ibrahim MA, Ashour OM, Ibrahim YF, El-Bitar HI, Gomaa W, Abdel-Rahim SR. Angiotensin-converting enzyme inhibition and angiotensin AT(1)-receptor antagonism equally improve doxorubicin-induced cardiotoxicity and nephrotoxicity. Pharmacol Res. 2009;60(5):373–81.CrossRefPubMed
8.
de Nigris F, Rienzo M, Schiano C, Fiorito C, Casamassimi A, Napoli C. Prominent cardioprotective effects of third generation beta blocker nebivolol against anthracycline-induced cardiotoxicity using the model of isolated perfused rat heart. Eur J Cancer. 2008;44(3):334–40.CrossRefPubMed
9.
Iarussi D, Auricchio U, Agretto A, Murano A, GiulianoM, Casale F, et al. Protective effect of coenzyme Q10 on anthracyclines cardiotoxicity: control study in children with acute lymphoblastic leukemia and non-Hodgkin lymphoma. Mol Aspects Med. 1994;15(Suppl 3):207-12.
10.
Whittaker JA, Al-Ismail SAD. Effect of digoxin and vitamin E in preventing cardiac damage caused by doxorubicin in acute myeloid leukaemia. Br Med J. 1984;288:283–4.CrossRef
11.
Dalen EV, Kremer L. Cardioprotective interventions for cancer patients receiving anthracyclines. Cochrane Database Syst Rev. 2011;6(2):CD003917.
12.
Vejpongsa P, Yeh ET. Prevention of anthracycline-induced cardiotoxicity: challenges and opportunities. J Am Coll Cardiol. 2014;64(9):938–45.CrossRefPubMed
13.
Tebbi CK, London WB, Friedman D, et al. Dexrazoxane-associated risk for acute myeloid leukemia/myelodysplastic syndrome and other secondary malignancies in pediatric Hodgkin’s disease. J Clin Oncol. 2007;25:493–500.CrossRefPubMed
14.
Doroshow JH. Effect of anthracycline antibiotics on oxygen radical formation in rat heart. Cancer Res. 1983;43(2):460–72.PubMed
15.
Dresdale AR, Barr LH, Bonow RO, et al. Prospective randomized study of the role of N-acetylcysteine in reversing doxorubicin-induced cardiomyopathy. Am J Clin Oncol. 1982;5:657–63.CrossRefPubMed
16.
Hasinoff BB, Patel D, Wu X. The oral iron chelator ICL670A (deferasirox) does not protect myocytes against doxorubicin. Free Radic Biol Med. 2003;35:1469–79.CrossRefPubMed
17.
Ji Young L, Jae Wook Y, Cheong Tae K, et al. Antioxidant activity of phenylpropanoid-esters isolated and identified from Platycodon grandiflorum A.DC. Phytochemistry. 2004;65:3033.CrossRef
18.
Kim T-W, Song I-B, Lee H-K, et al. Platycodin D, a triterpenoid sapoinin from Platycodon grandiflorum ameliorates cisplatin-induced nephrotoxicity in mice. Food Chem Toxicol. 2012;50(12):4254–9.CrossRefPubMed
19.
Fogli S, Nieri P, Breschi MC. The role of nitric oxide in anthracycline toxicity and prospects for pharmacologic prevention of cardiac damage. FASEB. 2004;18(6):664–75.CrossRef
20.
Cigremis Y, Parlakpinar H, Polat A, et al. Beneficial role of aminoguanidine on acute cardiomyopathy related to doxorubicin-treatment. Mol Cell Biochem. 2006;285(1-2):149–54.CrossRefPubMed
21.
Jang MH, Kim CJ, Kim EH, et al. Effects of Platycodon grandiflorum on lipopolysaccharide-stimulated production of prostaglandin E2, nitric oxide, and interleukin-8 in mouse microglial BV2 cells. J Med Food. 2006;9(2):169–74.CrossRefPubMed
22.
Han SB, Park SH, Lee KH, et al. Polysaccharide isolated from the radix of Platycodon grandiflorum selectively activates B cells and macrophages but not T cells. Int Immunopharmacol. 2001;1(11):1969–78.CrossRefPubMed
23.
Murtagh G, Lyons T, O’Connell E, et al. Late cardiac effects of chemotherapy in breast cancer survivors treated with adjuvant doxorubicin: 10-year follow-up. Breast Cancer Res Treat. 2016;156(3):501–6.CrossRefPubMed
24.
25.
Gagnier JJ, Boon H, Rochon P, CONSORT Group, et al. Recommendations for reporting randomized controlled trials of herbal interventions: explanation and elaboration. J Clin Epidemiol. 2006;59:1134–49.CrossRefPubMed
26.
Metadata
Title
Cardioprotective effect of Platycodon grandiflorum in patients with early breast cancer receiving anthracycline-based chemotherapy: study protocol for a randomized controlled trial
Authors
Wei Hao
Sheng Liu
Yuenong Qin
Chenping Sun
Liying Chen
Chunyu Wu
Yijia Bao
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2140-z

Other articles of this Issue 1/2017

Trials 1/2017 Go to the issue

Study protocol

Electroacupuncture plus moxibustion therapy for patients with major depressive disorder: study protocol for a randomized controlled trial

Study protocol

REstricted Fluid REsuscitation in Sepsis-associated Hypotension (REFRESH): study protocol for a pilot randomised controlled trial

Study protocol

A feasibility study investigating the acceptability and design of a multicentre randomised controlled trial of needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren’s contractures of the fingers (HAND-1): study protocol for a randomised controlled trial

Study protocol

Effectiveness of the addition of therapeutic alliance with minimal intervention in the treatment of patients with chronic, nonspecific low back pain and low risk of involvement of psychosocial factors: a study protocol for a randomized controlled trial (TalkBack trial)

Study protocol

United Kingdom Frozen Shoulder Trial (UK FROST), multi-centre, randomised, 12 month, parallel group, superiority study to compare the clinical and cost-effectiveness of Early Structured Physiotherapy versus manipulation under anaesthesia versus arthroscopic capsular release for patients referred to secondary care with a primary frozen shoulder: study protocol for a randomised controlled trial

Update

Statistical analysis plan for the Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM)