Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase IV Supportive care, Treatment Active 15 to 70 Other OLSG-0401 NCT00162955

Trial Description

Summary

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

Further Study Information

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).

Eligibility Criteria

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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Osaka City General Hospital

Masayuki Hino, MD, PhD

Study Chair

Hirohisa Nakamae, MD, PhD

Principal Investigator

Hirohisa Nakamae, MD, PhD		Ph: +81-6-6645-3881
		Email: hirohisa@msic.med.osaka-cu.ac.jp

Masayuki Hino, MD, PhD		Ph: +81-6-6645-3881
		Email: hinom@med.osaka-cu.ac.jp

Japan
	Osaka
	Osaka City General Hospital
		Hirohisa Nakamae, MD, PhD	Ph: +81-6-6645-3881
			Email: hirohisa@msic.med.osaka-cu.ac.jp
		Masayuki Hino, MD, PhD
			Email: hinom@med.osaka-cu.ac.jp
		Masayuki Hino, MD, PhD	Principal Investigator
		Hirohisa Nakamae, MD, PhD	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00162955
Information obtained from ClinicalTrials.gov on July 16, 2008