Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Heart and Blood Diseases

Symptoms and General Pathology

Substance Related Disorders

Wounds and Injuries

Breast Neoplasms

Cardiotoxicity

Breast Diseases

Skin Diseases

Heart Diseases

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

Antineoplastic Agents

All Drugs and Chemicals

Antihypertensive Agents

Anti-Infective Agents

Trastuzumab

Adrenergic beta-Antagonists

Ramipril

Angiotensin-Converting Enzyme Inhibitors

Bisoprolol

Enzyme Inhibitors

HIV Protease Inhibitors

Protease Inhibitors

Sympatholytics

Adrenergic Agents

Adrenergic beta-1 Receptor Antagonists

Adrenergic Antagonists

Neurotransmitter Agents

Placebo

Lorenzo Livi, MD, Prof

Icro Meattini, MD, Prof

The aim of the study is to analyze the protective impact on the cardiac damage of beta blockers and ACE inhibitors for breast cancer patients treated with anthracyclines-based chemotherapy with or without trastuzumab.

Over the years, due to the use of new generation therapeutic regimens, as well as the use of advanced radiation techniques, the curability of breast cancer reached an overall 10-year survival rate of approximately 80%.

Anthracyclines have a key role in the treatment of breast cancer. Many published studies showed a benefit of disease-free survival in patients with positive lymph nodes treated with anthracyclines-based regimens. Many anthracyclines and taxanes-based regimens are currently used in clinical practice in the treatment of breast cancer. Numerous randomized trials have confirmed the benefit of the addition of taxanes to anthracyclines.

Trastuzumab is a recombinant humanized monoclonal antibody with specificity for the extracellular domain of human epidermal growth factor receptor 2 (HER2). The use of trastuzumab administered sequentially or concurrently with adjuvant chemotherapy compared to chemotherapy in patients with HER2 positive was evaluated in several randomized trials. Many data concerning the incidence of adverse cardiovascular events acute, subacute and late are now available. The cardiac toxicity of anthracyclines may be acute, subacute and chronic. The acute toxicity occurs during or shortly after the infusion of the drug with arrhythmias, which in some cases leads to heart failure, pericarditis-myocarditis and electrocardiographic abnormalities. The acute toxicity is usually reversible in a dose-dependent manner. The acute and subacute toxicity are rare (1-4%). Data are available concerning clinically relevant cardiac toxicity with a chronic progressive deterioration of ventricular function up to heart failure.

Beside the cumulative dose risk factor, other unfavourable features such as advanced age, female sex, and the combination of anthracyclines and trastuzumab should be evaluated. In most cases, the late toxicity occurs within the first year following completion of chemotherapy but nevertheless the clinical manifestations can occur even after 10-20 years. This fact suggests that in women treated in (neo)adjuvant setting is strongly necessary an echocardiographic monitoring even after a longer time.

The aim of the study is to analyze the protective impact on the cardiac damage of beta blockers and ACE inhibitors for breast cancer patients treated with anthracyclines-based chemotherapy with or without trastuzumab, using myocardial strain imaging monitoring.

Both participants and Care Providers are not aware of intervention allocation.

Cardiotoxicity Prevention in Breast Cancer Patients Treated With Anthracyclines and/or Trastuzumab

Role of ACE Inhibitors and Beta Blockers as Cardiotoxicity Prevention in Breast Cancer Patients Treated With (Neo)Adjuvant Anthracyclines and/or Trastuzumab: a Four Arm, Placebo Control, Randomized Trial

Change in LVEF (3-dimensional and 2-dimensional) at time-frame

University of Florence

Azienda Ospedaliero-Universitaria Careggi

Full Professor

Behaviors and Mental Disorders

Nervous System Diseases

Rare Diseases

Cognitive Dysfunction

Glioblastoma

Brain Neoplasms

Amnesia

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Neuroepithelioma

Ramipril will be taken once daily by mouth. It will be titrated during the first 3 weeks of chemoradiation to the highest tolerable dose (2.5-5 mg). This dose will be taken each day until 4 months post-chemoradiation treatment (22 weeks).

Michael D Chan, MD

This study is to determine if an oral drug called Ramipril can lower the chance of memory loss in patients with glioblastoma getting chemoradiation. Patients will take Ramipril during chemoradiation and continue until 4 months post-treatment. Memory loss will be assessed using several neurocognitive tests throughout the duration of the study.

This is a pilot study of an oral drug Ramipril to prevent cognitive decline in glioblastoma patients receiving partial brain radiation and concurrent and adjuvant temozolomide . Ramipril will be titrated to the highest tolerable dose during chemoradiation (2.5-5 mg). Once this dose is determined, the patient will continue at this dose for 4 months after the completion of chemoradiation. Patients will be followed until 5 months post chemoradiation for compliance, toxicity, cognitive decline and participant reported outcomes (PRO).

Testing Ramipril to Prevent Memory Loss in People With Glioblastoma

A Single Arm, Pilot Study of Ramipril for Preventing Radiation-Induced Cognitive Decline in Glioblastoma (GBM) Patients Receiving Brain Radiotherapy

Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.

HVLT-R measures verbal learning and memory. It consists of a 12-item word list which is read to subjects on three successive learning trials. Free recall scores are recorded for each learning trial. Scores for immediate recall (total of three trials), delayed recall (total number of words recalled after 20 minutes), and recognition (total number of words correctly identified) will be the variables derived from the HVLT-R.

Part A of the TMT measures attention and visual motor skills and processing speed and requires subjects to connect 25 numbered circles in the proper sequence (1-2-3-...) as quickly as possible. TMT-B is similar except subjects are required to connect dots in an alternating numerical and alphabetical sequence (1-A-2-B-...). TMT-B with its added complexity and set shifting requirements is a widely used measure of executive function. The score for TMT-A and TMT-B is the total time in seconds required to complete the task. Scores can also be generated for number of errors and number of circles correctly connected.

The COWA measures speed of mental processing, verbal fluency, and executive function. Subjects are asked to name as many words as possible all beginning with a specified letter. A total of three trials are administered, each with a different letter (F-A-S). The score on the COWA is the total number of words named across the three trials minus repetitions.

Provides an assessment of premorbid intellectual functioning comparable to a verbal IQ and thus is a proxy for cognitive reserve. This vocabulary test requires respondents to read a target word and select one of four words that most closely means the same thing. Score is total correct of 40 items and will be used in conjunction with the other neurocognitive results.

Measured by the percent of patients who took 75% of the Ramipril doses and completed the neurocognitive battery of tests

A 50-item questionnaire with a 20-item brain cancer specific section, used to assess the physical and psychosocial functioning and symptom experience. All of the scales and single-item measures range in score from 0 to 100 with standardization.

Measured by the first significant decline of the HVLT-R.

Measured by the first significant decline of the TMT A \& B

Measured by the first significant decline of the COWA

Measured by quantitative polymerase chain reaction (PCR) using patient serum via a blood test

Comparison of HVLT-R results between groups at study end.

Comparison of TMT A \& B results between groups at study end.

Comparison of COWA results between groups at study end.

Comparison of EORTCQLQ30/BN20 results between groups at study end.

National Cancer Institute (NCI)

Wake Forest University Health Sciences

Hypertension

Vascular Diseases

Anti-Arrhythmia Agents

Cardiotonic Agents

Vasoconstrictor Agents

Hormones

Losartan

Lisinopril

Benazepril

Angiotensin II

Giapreza

Angiotensinogen

Angiotensin II Type 1 Receptor Blockers

Angiotensin Receptor Antagonists

Protective Agents

Patients receive oral benazepril hydrochloride once daily on days 1-7.

Patients receive oral lisinopril once daily on days 1-7.

Patients receive oral ramipril twice daily on days 1-7.

Patients receive oral losartan potassium once daily on days 1-7.

lisinopril

losartan potassium

laboratory biomarker analysis

benazepril hydrochloride

ramipril

William Petty

RATIONALE: Benazepril hydrochloride, lisinopril, ramipril, and losartan potassium may help lower blood pressure.

PURPOSE: This phase II trial is studying how well benazepril hydrochloride, lisinopril, ramipril, or losartan potassium works in treating hypertension in patients with solid tumors.

PRIMARY OBJECTIVES:

I. To determine which drug has the greatest effect on Ang-(1-7) levels in cancer patients with hypertension.

SECONDARY OBJECTIVES:

I. To determine the effect of these drugs on levels of Ang II, VEGF, PlGF, and ACE in the same patients.

OUTLINE: Patients are randomized to 1 of 4 treatment arms.

* ARM I: Patients receive oral benazepril hydrochloride once daily on days 1-7.
* ARM II: Patients receive oral lisinopril once daily on days 1-7.
* ARM III: Patients receive oral ramipril twice daily on days 1-7.
* ARM IV: Patients receive oral losartan potassium once daily on days 1-7. In all arms, treatment continues in the absence of unacceptable toxicity.

Benazepril Hydrochloride, Lisinopril, Ramipril, or Losartan Potassium in Treating Hypertension in Patients With Solid Tumors

A Phase II Study of the Effect of ACE Inhibitors on Pro-Angiogenic Hormones in Cancer Patients With Hypertension

Patients receive oral benazepril hydrochloride once daily on days 1-7.

laboratory biomarker analysis: Correlative studies

benazepril hydrochloride: Given orally

Arm I

Patients receive oral lisinopril once daily on days 1-7.

lisinopril: Given orally

laboratory biomarker analysis: Correlative studies

Arm II

Patients receive oral ramipril twice daily on days 1-7.

laboratory biomarker analysis: Correlative studies

ramipril: Given orally

Arm III

Patients receive oral losartan potassium once daily on days 1-7.

losartan potassium: Given orally

laboratory biomarker analysis: Correlative studies

Arm IV

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

William J. Petty, MD

Changes in Ang1-7 Levels Among Patients After ACE-I/ARB Treatment Measured in Picogram/Milliliter

Data were not analyzed due to insufficient accrual to the study and lack of statistical power.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cardiotoxicity Prevention in Breast Cancer Patients Treated With Anthracyclines and/or Trastuzumab	NCT02236806	Breast Cancer Cardiotoxicity	Bisoprolol Ramipril Placebo	18 Years -	Azienda Ospedaliero-Universitaria Careggi
Testing Ramipril to Prevent Memory Loss in People With Glioblastoma	NCT03475186	Glioblastoma Radiotherapy; C... Cognitive Decli... Chemoradiation	Ramipril	18 Years -	Wake Forest University Health Sciences
Benazepril Hydrochloride, Lisinopril, Ramipril, or Losartan Potassium in Treating Hypertension in Patients With Solid Tumors	NCT01234922	Hypertension Unspecified Adu...	lisinopril losartan potass... laboratory biom... benazepril hydr... ramipril	18 Years -	Wake Forest University Health Sciences
Cardiotoxicity Prevention in Breast Cancer Patients Treated With Anthracyclines and/or Trastuzumab	NCT02236806	Breast Cancer Cardiotoxicity	Bisoprolol Ramipril Placebo	18 Years -	Azienda Ospedaliero-Universitaria Careggi
Testing Ramipril to Prevent Memory Loss in People With Glioblastoma	NCT03475186	Glioblastoma Radiotherapy; C... Cognitive Decli... Chemoradiation	Ramipril	18 Years -	Wake Forest University Health Sciences

Spots Global Cancer Trial Database for ramipril

Every month we try and update this database with for ramipril cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ramipril

Every month we try and update this database with for ramipril cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ramipril cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.