The Multi-centers Trial for Patients With Non-Hodgkin's Lymphoma to Assess the Protective Effect of Valsartan on Chronic Cardiotoxicity Induced by CHOP
15 Years
70 Years
Both
Non-Hodgkin's Lymphoma
Trial Information
The Multi-centers Trial for Patients With Non-Hodgkin's Lymphoma to Assess the Protective Effect of Valsartan on Chronic Cardiotoxicity Induced by CHOP
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).
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Cardiac Event after 3rd and 6th course of CHOP(-R)
Outcome Time Frame:
Basically 14-21 (at a maximum 28) days after the start of 3rd and 6th course of CHOP(-R).
Safety Issue:
No
Principal Investigator
Masayuki Hino, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Graduate School of Medicine, Osaka City University
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
OLSG-0401
NCT ID:
NCT00162955
Start Date:
May 2004
Completion Date:
September 2010
Related Keywords:
- Non-Hodgkin's Lymphoma
- untreated adult Non-Hodgkin's Lymphoma
- CHOP protocol
- Angiotensin II Type 1 Receptor Blockers
- Cardiomyopathy
- Lymphoma
- Lymphoma, Non-Hodgkin
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