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Cardiotoxicity induced by epirubicin-based chemotherapy for early stage Breast Cancer Patients with Diabetes and the Protection of Dexrazoxane

Cardiotoxicity induced by epirubicin-based chemotherapy for early stage Breast Cancer Patients with Diabetes and the Protection of Dexrazoxane

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-16007759
Enrollment
Unknown
Registered
2016-01-14
Start date
2012-10-08
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

tumour and cardiology

Interventions

NDM2 chemotherapy:NDM2 chemotherapy
DM2 chemotherapy:DM2 chemotherapy
chemotherapy plus dexrazoxane:chemotherapy plus dexrazoxane

Sponsors

Fourth Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Inclusion criteria: histologically confirmed diagnosis of early breast cancer; candidate for treatment with an epirubicin-based adjuvant chemotherapy regimen according to international standardized protocols; completely resected unilateral breast cancer; blood pressure within the normal range (=50%; normal hepatic and renal function (bilirubin <=1.5 mg/dl, creatinine <=2.0 mg/dl); normal sinus rhythm; no concomitant medications such as angiotensin converting enzyme inhibitor (ACEI), B receptor blocker (B-block), Calcium antagonists (CCB) or oxidative stress parameters such as Vc, VE.

Exclusion criteria

Exclusion criteria: Acute DM2 complications; severe chronic DM2 complications; acute stress reactions such as external injury, surgery or infection one week before blood collection; history of cardiac disease; hypertension; hypo/hyperthyroidism; hemolytic, hepatic, and renal diseases; present or past history of coronary artery disease, symptoms of congestive heart failure, established structural heart disease such as cardiomyopathy or valvular disease; history of chemotherapy or radiotherapy; ST-segment or T-wave changes specifically for myocardial ischemia, Q waves, and incidental left bundle branch block on electrocardiography.

Design outcomes

Primary

MeasureTime frame
Heart rate variability index;Echocardiographic index;SOD and MDA;

Countries

China

Contacts

Public ContactFangyi Sun
ydsysfy2012@163.com+86 13831128410

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026