Prevention of CHOP-induced Chronic Cardiotoxicity

Non-Hodgkin's Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00162955
• Other study ID #: OLSG-0401
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2005
• Last updated: May 7, 2012
• Start date: May 2004
• Est. completion date: September 2010

Study information

• Verified date: September 2010
• Source: Osaka City University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

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.

Locations

Country	Name	City	State
Japan	Graduate School of Medicine, Osaka City University	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Osaka City University

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Toko H, Oka T, Zou Y, Sakamoto M, Mizukami M, Sano M, Yamamoto R, Sugaya T, Komuro I. Angiotensin II type 1a receptor mediates doxorubicin-induced cardiomyopathy. Hypertens Res. 2002 Jul;25(4):597-603. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	No
Secondary	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).	No