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Prevention of CHOP-induced Chronic Cardiotoxicity

Primary Purpose

Non-Hodgkin's Lymphoma

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Valsartan
Sponsored by
Osaka City University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Non-Hodgkin's Lymphoma focused on measuring untreated adult Non-Hodgkin's Lymphoma, CHOP protocol, Angiotensin II Type 1 Receptor Blockers, Cardiomyopathy

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Graduate School of Medicine, Osaka City University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ARB administration

non-administration

Arm Description

80mg/day from the day of the start of 1st CHOP until the completion of all the evaluations

ARB non-administration group

Outcomes

Primary Outcome Measures

Cardiac Event after 3rd and 6th course of CHOP(-R)

Secondary Outcome Measures

Changes of ECG, UCG and serum markers after 3 and 6 courses of CHOP (-R)

Full Information

First Posted
September 9, 2005
Last Updated
May 7, 2012
Sponsor
Osaka City University
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1. Study Identification

Unique Protocol Identification Number
NCT00162955
Brief Title
Prevention of CHOP-induced Chronic Cardiotoxicity
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Osaka City University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma
Keywords
untreated adult Non-Hodgkin's Lymphoma, CHOP protocol, Angiotensin II Type 1 Receptor Blockers, Cardiomyopathy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARB administration
Arm Type
Experimental
Arm Description
80mg/day from the day of the start of 1st CHOP until the completion of all the evaluations
Arm Title
non-administration
Arm Type
No Intervention
Arm Description
ARB non-administration group
Intervention Type
Drug
Intervention Name(s)
Valsartan
Other Intervention Name(s)
Diovan
Intervention Description
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.
Primary Outcome Measure Information:
Title
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).
Secondary Outcome Measure Information:
Title
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masayuki Hino, MD, PhD
Organizational Affiliation
Graduate School of Medicine, Osaka City University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hirohisa Nakamae, MD, PhD
Organizational Affiliation
Graduate School of Medicine, Osaka City University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Graduate School of Medicine, Osaka City University
City
Osaka
ZIP/Postal Code
545-8585
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
12358147
Citation
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. doi: 10.1291/hypres.25.597.
Results Reference
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Prevention of CHOP-induced Chronic Cardiotoxicity

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