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Prevention of CHOP-induced Chronic Cardiotoxicity

This study has been completed.
Sponsor:
Information provided by:
Osaka City University
ClinicalTrials.gov Identifier:
NCT00162955
First received: September 9, 2005
Last updated: May 7, 2012
Last verified: September 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Non-Hodgkin's Lymphoma
 Drug: Valsartan
 Phase 4

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

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
Drug Information available for: Valsartan
U.S. FDA Resources

Further study details as provided by Osaka City University:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: May 2004
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Diovan
No Intervention: non-administration
ARB non-administration group

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).

  Eligibility

Ages Eligible for Study:   15 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00162955

Locations
Japan
Graduate School of Medicine, Osaka City University
Osaka, Japan, 545-8585
Sponsors and Collaborators
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
  More Information

Publications:

Responsible Party: Hirohisa Nakamae, MD. PhD., Osaka City University
ClinicalTrials.gov Identifier: NCT00162955     History of Changes
Other Study ID Numbers: OLSG-0401
Study First Received: September 9, 2005
Last Updated: May 7, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Osaka City University:
untreated adult Non-Hodgkin's Lymphoma
CHOP protocol
Angiotensin II Type 1 Receptor Blockers
Cardiomyopathy

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Valsartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013