NCT00162955

Prevention of CHOP-induced Chronic Cardiotoxicity

The Multi-centers Trial for Patients With Non-Hodgkin's Lymphoma to Assess the Protective Effect of Valsartan on Chronic Cardiotoxicity Induced by CHOP

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Osaka City University · Academic / Other
• Sex: All
• Age: 15 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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).

Conditions

• Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	Valsartan	Patients allocated into ARB administration group take Valsartan (80mg/day) from the day of the start of 1st CHOP until the completion of all the evaluations.

Timeline

• Start date: 2004-05-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2005-09-13
• Last updated: 2012-05-08

Locations

1 site across 1 country: Japan