Prevention of CHOP-induced Chronic Cardiotoxicity
The purpose of this study is to assess the protective effect of Valsartan on chronic cardiotoxicity induced by CHOP.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||The Multi-centers Trial for Patients With Non-Hodgkin's Lymphoma to Assess the Protective Effect of Valsartan on Chronic Cardiotoxicity Induced by CHOP|
- Cardiac Event after 3rd and 6th course of CHOP(-R) [ Time Frame: Basically 14-21 (at a maximum 28) days after the start of 3rd and 6th course of CHOP(-R). ] [ Designated as safety issue: No ]
- Changes of ECG, UCG and serum markers after 3 and 6 courses of CHOP (-R) [ Time Frame: 14-21 (at a maximum 28) days after the start of 3rd and 6th course of CHOP(-R). ] [ Designated as safety issue: No ]
|Study Start Date:||May 2004|
|Study Completion Date:||September 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Experimental: ARB administration
80mg/day from the day of the start of 1st CHOP until the completion of all the evaluations
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.
Other Name: Diovan
No Intervention: non-administration
ARB non-administration group
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).
|Graduate School of Medicine, Osaka City University|
|Osaka, Japan, 545-8585|
|Study Chair:||Masayuki Hino, MD, PhD||Graduate School of Medicine, Osaka City University|
|Principal Investigator:||Hirohisa Nakamae, MD, PhD||Graduate School of Medicine, Osaka City University|