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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014