Prevention of CHOP-induced Chronic Cardiotoxicity

Phase 4

Completed

• Conditions: Non-Hodgkin's Lymphoma
• Interventions: Drug: Valsartan

• Registration Number: NCT00162955
• Lead Sponsor: Osaka City University

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).

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-13
• Status Verified: 2010-09
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Last Update Submitted: 2012-05-07
• Last Update Posted: 2012-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ARB administration	Valsartan	80mg/day from the day of the start of 1st CHOP until the completion of all the evaluations

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Graduate School of Medicine, Osaka City University; 🇯🇵 Osaka, Japan