Prevention of CHOP-induced Chronic Cardiotoxicity

May 7, 2012 updated by: Osaka City University

The Multi-centers Trial for Patients With Non-Hodgkin's Lymphoma to Assess the Protective Effect of Valsartan on Chronic Cardiotoxicity Induced by CHOP

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Osaka, Japan, 545-8585
        • Graduate School of Medicine, Osaka City University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ARB administration
80mg/day from the day of the start of 1st CHOP until the completion of all the evaluations
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.
Other Names:
  • Diovan
No Intervention: non-administration
ARB non-administration group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiac Event after 3rd and 6th course of CHOP(-R)
Time Frame: Basically 14-21 (at a maximum 28) days after the start of 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

Outcome Measure
Time Frame
Changes of ECG, UCG and serum markers after 3 and 6 courses of CHOP (-R)
Time Frame: 14-21 (at a maximum 28) days after the start of 3rd and 6th course of CHOP(-R).
14-21 (at a maximum 28) days after the start of 3rd and 6th course of CHOP(-R).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Osaka City University

Investigators

  • Study Chair: Masayuki Hino, MD, PhD, Graduate School of Medicine, Osaka City University
  • Principal Investigator: Hirohisa Nakamae, MD, PhD, Graduate School of Medicine, Osaka City University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 13, 2005

Study Record Updates

Last Update Posted (Estimate)

May 8, 2012

Last Update Submitted That Met QC Criteria

May 7, 2012

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OLSG-0401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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