Prevention of CHOP-induced Chronic Cardiotoxicity

Osaka City University

Status and phase

Completed

Phase 4

Conditions

Non-Hodgkin's Lymphoma

Treatments

Drug: Valsartan

Study type

Interventional

Funder types

Other

Identifiers

NCT00162955

OLSG-0401

Details and patient eligibility

About

The purpose of this study is to assess the protective effect of Valsartan on chronic cardiotoxicity induced by CHOP.

Full description

Doxorubicin has been one of the most important key drugs in treatment for malignancies. However, its use is limited by dose-dependent cumulative cardiotoxicity. This multi-centers trial was designed to investigate the preventive effect of Valsartan, the angiotensin II type 1 receptor blocker (ARB) on chronic cardiotoxicity due to doxorubicin based chemotherapy. Patients with untreated non-Hodgkin's lymphoma who are scheduled to receive at least 6 courses of the standard CHOP (-R) will be randomized by the minimization methods to the treatment group with Valsartan (80mg once daily by oral during entire 6 courses of CHOP) or control group. Cardiac function will be evaluated in detail before and after 3 and 6 courses of CHOP (-R).

Enrollment

150 patients

Sex

All

Ages

15 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Clinical diagnosis of non-Hodgkin's lymphoma (NHL)
Untreated lymphoma
Performance status from 0 to 1,
Total serum bilirubin < 2.0 mg/dl
Serum creatinine level < 2.0 mg/dl
Ejection fraction of the left ventricle >50 %
Systolic blood pressure at rest being 90 mmHg or more

Exclusion criteria

Severe complication including chronic or acute heart failure, angina, old myocardial infarction, liver cirrhosis, and interstitial pneumonia
Pregnancy, nursing mothers or women of child-bearing potential
Hypertension under medication
Diabetes mellitus under medication
Hyperthyroidism, nephrotic syndrome, Cushing's syndrome
Atrial arrythmias
Severe psychopathy
Cerebrovascular accidents within the past 3 months
Positive serum HBs antigen or HCV antibody
A history of renal failure
A contraindication to A-II antagonists or noncompliance
Treatment with any of the following drugs within the past 3 months : A-II antagonists, ACE inhibitors, vitamin E, probucol, calcium antagonists, beta-blockers, and steroid pulse therapy.