Prevention of CHOP-induced Chronic Cardiotoxicity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2010-09-30

Brief Summary

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

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Detailed Description

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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

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Non-Hodgkin's Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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ARB administration

80mg/day from the day of the start of 1st CHOP until the completion of all the evaluations

Group Type EXPERIMENTAL

Valsartan

Intervention Type DRUG

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.

non-administration

ARB non-administration group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Diovan

Eligibility Criteria

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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.

Minimum Eligible Age

15 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No