Non-Hodgkin's LymphomaPhase 4NCT00162955
Prevention of CHOP-induced Chronic Cardiotoxicity
A Phase 4 study testing Valsartan in people with Non-Hodgkin's Lymphoma, run by Osaka City University at 1 site in Japan.
Trial summary
The purpose of this study is to assess the protective effect of Valsartan on chronic cardiotoxicity induced by CHOP. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- Valsartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteJapan
- Study dates
- May 2004to Sep 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
Japan1 site
Graduate School of Medicine, Osaka City University
Osaka, Osaka, 545-8585
About this study
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
The purpose of this study is to assess the protective effect of Valsartan on chronic cardiotoxicity induced by CHOP.
Read the 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).
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- Valsartan
- Keywords
- untreated adult Non-Hodgkin's Lymphoma, CHOP protocol, Angiotensin II Type 1 Receptor Blockers, Cardiomyopathy
- Medical subject headings
- Lymphoma, Non-Hodgkin, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValsartanDrug
Also called Diovan
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.
| Study group | Role | What they receive |
|---|---|---|
| ARB administration | Experimental | 80mg/day from the day of the start of 1st CHOP until the completion of all the evaluations Receives: Drug: Valsartan |
| non-administration | No intervention | ARB non-administration group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Event after 3rd and 6th course of CHOP(-R)
Measured: Basically 14-21 (at a maximum 28) days after the start of 3rd and 6th course of CHOP(-R).
Secondary outcomes (1)
Changes of ECG, UCG and serum markers after 3 and 6 courses of CHOP (-R)
Measured: 14-21 (at a maximum 28) days after the start of 3rd and 6th course of CHOP(-R).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startMay 2004
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osaka City University
- Sponsor type
- University, hospital or other
- Investigators
- Masayuki Hino, MD, PhD, Study chair, Graduate School of Medicine, Osaka City UniversityHirohisa Nakamae, MD, PhD, Principal investigator, Graduate School of Medicine, Osaka City University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00162955
- Sponsor's protocol ID
- OLSG-0401
- Status last verified
- Sep 2010
- First submitted
- 9 Sep 2005
- Last updated
- 8 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 12358147
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00162955
- Acronym / sponsor ID
- OLSG-0401
- Conditions
- Non-Hodgkin's Lymphoma
- Keywords
- untreated adult Non-Hodgkin's Lymphoma, CHOP protocol, Angiotensin II Type 1 Receptor Blockers, Cardiomyopathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Osaka City UniversityUniversity, hospital or other
- Study start
- May 2004
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 13 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARB administration | Experimental | Drug: Valsartan80mg/day from the day of the start of 1st CHOP until the completion of all the evaluations |
| non-administration | No intervention | –ARB non-administration group |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ValsartanAlso: DiovanPatients 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. | Drug | ARB administration |
Primary outcome
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).
1 secondary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2012.
- Background: PubMed 12358147Toko 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masayuki Hino, MD, PhD study chair
Graduate School of Medicine, Osaka City University
Hirohisa Nakamae, MD, PhD principal investigator
Graduate School of Medicine, Osaka City University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Valsartan in people with Non-Hodgkin's Lymphoma, run by Osaka City University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00162955, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2012.