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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00162955

Enrollment

150

Registered

2005-09-13

Start date

2004-05-31

Completion date

2010-09-30

Last updated

2012-05-08

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

Conditions

Non-Hodgkin's Lymphoma

Keywords

untreated adult Non-Hodgkin's Lymphoma, CHOP protocol, Angiotensin II Type 1 Receptor Blockers, Cardiomyopathy

Brief 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).

Interventions

DRUGValsartan

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame
Cardiac Event after 3rd and 6th course of CHOP(-R)	Basically 14-21 (at a maximum 28) days after the start of 3rd and 6th course of CHOP(-R).

Secondary

Measure	Time frame
Changes of ECG, UCG and serum markers after 3 and 6 courses of CHOP (-R)	14-21 (at a maximum 28) days after the start of 3rd and 6th course of CHOP(-R).

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026