Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Small Cell Lung Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Dyspnea

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiration Disorders

Signs and Symptoms, Respiratory

Small Cell Lung Cancer

Antihypertensive Agents

Cardiotonic Agents

All Drugs and Chemicals

Anti-Infective Agents

Lisinopril

Enzyme Inhibitors

Angiotensin-Converting Enzyme Inhibitors

HIV Protease Inhibitors

Protease Inhibitors

Protective Agents

Beginning within 7 days of beginning radiation therapy, patients receive lisinopril PO QD on days 1-7.

Beginning within 7 days of beginning radiation therapy, patients receive placebo PO QD on days 1-7.

lisinopril

placebo

Robert Miller, M.D.

This pilot clinical trial studies lisinopril in reducing shortness of breath caused by radiation therapy in patients with lung cancer. Lisinopril may decrease the side effects caused by radiation therapy in patients with lung cancer.

PRIMARY OBJECTIVES:

I. To explore the adverse event profile of lisinopril, during and after external beam radiation therapy (RT) to the lung.

SECONDARY OBJECTIVES:

I. To explore the level of patient-reported acute respiratory distress (dyspnea) during and after external beam RT.

II. To explore the level of patient-reported symptoms during and after external beam RT.

III. To explore the impact of lisinopril treatment on patient quality of life (QOL) during and after external beam RT.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Beginning within 7 days of beginning radiation therapy, patients receive lisinopril orally (PO) once daily (QD) on days 1-7.

ARM II: Beginning within 7 days of beginning radiation therapy, patients receive placebo PO QD on days 1-7.

In both arms, treatment repeats every 7 days for until 3 months after completion of radiation therapy in the absence of disease progression or unacceptable toxicity.

Lisinopril in Reducing Shortness of Breath Caused by Radiation Therapy in Patients With Lung Cancer

A Double-Blind Pilot Study to Measure the Effect of Lisinopril vs. Placebo on Pulmonary Distress in Patients Receiving External Beam Radiotherapy to the Lung

Incidence of grade 3 or higher hypotension, acute kidney injury, allergic reaction, or anaphylaxis, as measured using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. Descriptive statistics of frequency (percentage) will be used to summarize adverse event (AE) incidence and severity in the lisinopril and placebo arms separately.

Acute respiratory distress (dyspnea), measured using of the maximum score, at any time, of the shortness of breath question (Item #4 "How much shortness of breath do you have?") on the Lung Cancer Symptom Scale (LCSS) (Worst Dyspnea Score). The LCSS tool contains 6 major symptoms associated with lung malignancies and their effect on overall symptomatic distress, functional activities, and global quality of life (QOL). The item scale ranges from 0-10 (0 = None; 10 = As much as it could be) where the LCSS scoring algorithm is applied to convert to a 0-100 point scale where 100 is best quality of life (QOL), for comparability. Patient scores range from 0 to 100, where 100 was best QOL (i.e. less pulmonary distress).

Experience shortness of breath during exercise as measured using Item #3 ("Over the past week, did you experience shortness of breath when you exercise or exert yourself?") on the Symptom Experience Questionnaire (SEQ) at Baseline. The item scale ranges from 0-10 (0 = Not at all; 10 = As bad as it can be) where the SEQ scoring algorithm is applied to convert to a 0-100 point scale where 100 is best quality of life (QOL), for comparability.

Dyspnea when climbing as measured using item #5 ("Were you short of breath when you climbed stairs?") of the EORTC-QLQ-LC13 at Week 4. The item scale ranges from 1-4 (1 = Not at all; 4 = Very Much) where the EORTC-QLQ-LC13 scoring algorithm is applied to convert to a 0-100 point scale where 100 is best quality of life (QOL), for comparability.

Total LCSS score as measured using the Lung Cancer Symptom Scale (LCSS) at Week 4. The item scale ranges from 0-10 (0 = None; 10 = As much as it could be) where the LCSS scoring algorithm is applied to convert to a 0-100 point scale where 100 is best quality of life (QOL), for comparability.

National Cancer Institute (NCI)

Mayo Clinic

Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.

Beginning within 7 days of beginning radiation therapy, patients receive lisinopril PO QD.

Arm I (Lisinopril)

Beginning within 7 days of beginning radiation therapy, patients receive placebo PO QD.

Arm II (Placebo)

Total

Age, Continuous

Sex: Female, Male

Terence T Sio, MD, MS

Incidence of Grade 3 or Higher Hypotension, Acute Kidney Injury, Allergic Reaction, or Anaphylaxis, as Measured Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0

Patients who completed the LCSS Item #4 at any time during the study are included in this analysis.

Acute Respiratory Distress (Dyspnea), Measured Using of the Maximum Score, at Any Time, of the Shortness of Breath Question (Item #4) on the LCSS (Worst Dyspnea Score)

Patients who completed Item #3 on the SEQ at week 4 are included in this analysis.

Experience Shortness of Breath During Exercise as Measured Using Item #3 on the Symptom Experience Questionnaire (SEQ) at Week 4

Patients who completed item #5 on the EORTC-QLQ-LC13 at week 4 are included in this analysis.

Quality of Life (Dyspnea When Climbing Stairs) Assessed Using Item #5 of the European Organization for Research on the Treatment of Cancer Lung Cancer Module Survey (EORTC-QLQ-LC13) at Week 4

Patients who completed the LCSS at week 4 are included in this analysis.

Total LCSS Score as Measure by the Lung Cancer Symptom Scale (LCSS) at Week 4

Overall Study

Skin and Connective Tissue Diseases

Heart and Blood Diseases

Substance Related Disorders

Wounds and Injuries

Recurrence

Breast Neoplasms

Cardiotoxicity

Breast Neoplasms, Male

Breast Diseases

Skin Diseases

Heart Diseases

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

Breast Cancer, Male

Antineoplastic Agents

Channel Blockers

Vasodilator Agents

Bone Density Conservation Agents

Trastuzumab

Carvedilol

Adrenergic beta-Antagonists

Adrenergic Agents

Adrenergic Antagonists

Neurotransmitter Agents

Antioxidants

Calcium

Calcium Channel Blockers

Calcium, Dietary

Hormones

Adrenergic alpha-1 Receptor Antagonists

Adrenergic alpha-Antagonists

Patients receive oral lisinopril once daily.

Patients receive oral Coreg CR® once daily.

Patients receive oral placebo once daily.

Coreg CR®

Maya Guglin, MD, PhD

Pamela N. Munster, MD

RATIONALE: Lisinopril or Coreg CR®, may help reduce side effects caused by trastuzumab. It is not yet known whether lisinopril or Coreg CR® are more effective than a placebo in reducing side effects caused by trastuzumab.

PURPOSE: This phase II trial is studying lisinopril and Coreg CR® to see how well they work compared with a placebo in reducing side effects in patients with HER2-positive breast cancer receiving trastuzumab.

OBJECTIVES:

Primary

* The primary objective of this study is to determine if administration of lisinopril or Coreg CR®, compared to placebo, will reduce the incidence of trastuzumab-induced cardiotoxicity, as measured by LVEF, in patients receiving adjuvant, or neoadjuvant,therapy for HER2 positive breast cancer.

Secondary

* To determine whether subjects randomized to active agent have fewer interruptions in trastuzumab therapy due to cardiomyopathy.
* To determine whether the treatment effect is consistent in anthracycline and nonanthracycline patient cohorts
* To compare changes in HRQL among the treatment groups during the study intervention
* To evaluate the long term effects on the prevention of cardiomyopathy and impact on HRQL for either or both study agents
* To compare the predictive value of troponin I and BNP in the identification of trastuzumab-induced cardiotoxicity

OUTLINE: This is a multicenter study. Patients are stratified according to chemotherapy comprising an anthracycline (yes vs no). Patients are randomized to 1 of 3 treatment arms.

* Arm I: Patients receive oral lisinopril once daily.
* Arm II: Patients receive oral Coreg CR® once daily.
* Arm III: Patients receive oral placebo once daily.

In all arms, study treatment begins with the first dose of trastuzumab and continues for up to 52 weeks or until the end of trastuzumab therapy.

Quality of life is assessed using the EORTC QLQ-C30 questionnaire at baseline, at 52 weeks (or at the end of trastuzumab therapy), and at 18 and 24 months (or 6 and 12 months after the completion of trastuzumab).

After completion of study treatment, patients are followed up at 3, 6, 9, and 12 months.

Lisinopril or Coreg CR® in Reducing Side Effects in Women With Breast Cancer Receiving Trastuzumab

Phase II Placebo-controlled Trial of Lisinopril and Coreg CR® to Reduce Cardiotoxicity in Patients With Breast Cancer Receiving (Neo)Adjuvant Chemotherapy With Trastuzumab (Herceptin®)

Reduction in incidence of trastuzumab-induced cardiotoxicity after 52 weeks of treatment as measured by preservation of Left Ventricular Ejection Fraction (LVEF). Number of Patients who experienced a cardiotoxicity.

Number of Participants with Left Ventricular Ejection Fraction (LVEF) drop to \<50%

Measure indicates the number of patients who had an interruption of trastuzumab for any reason

Quality-of-life changes as assessed by North European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30), which measures the quality of life of cancer patients. Higher score indicates higher quality of life. Score range is 0-100. The questionnaire was administered at baseline and at 52 weeks.

Number of Participants with cardiotoxicity-free survival at 750 days from baseline

University of South Florida

Adverse Events were collected from patient at each study visit.

Patients receive oral lisinopril once daily.

lisinopril: Given orally

Arm I Lisinopril

Patients receive oral Coreg CR® once daily.

Coreg CR®: Given orally

Arm II Coreg CR®

Patients receive oral placebo once daily.

placebo: Given orally

Arm III Placebo

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Did not have information for 4 participants

Body Mass Index (BMI)

Number of participants who experienced cardiotoxicity

Number of Participants With Trastuzumab-Induced Cardiotoxicity After 52 Weeks of Treatment

Number of Participants With LVEF Decrease to <50%

Number of patients who had an interruption of trastuzumab for any reason

Number of Patients With Trastuzumab Course Interruption

Mean change from baseline to 52-week endpoint

Quality-of-life Changes Between Baseline and 52-weeks

Number of Participants With Cardiotoxicity-free Survival at 750 Days From Baseline

Hypertension

Vascular Diseases

Anti-Arrhythmia Agents

Vasoconstrictor Agents

Losartan

Ramipril

Benazepril

Angiotensin II

Giapreza

Angiotensinogen

Angiotensin II Type 1 Receptor Blockers

Angiotensin Receptor Antagonists

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.

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

Wake Forest University Health Sciences

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

Age, Categorical

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
Lisinopril in Reducing Shortness of Breath Caused by Radiation Therapy in Patients With Lung Cancer	NCT01880528	Dyspnea Non-small Cell ... Small Cell Lung...	lisinopril placebo	18 Years -	Mayo Clinic
Lisinopril in Reducing Shortness of Breath Caused by Radiation Therapy in Patients With Lung Cancer	NCT01880528	Dyspnea Non-small Cell ... Small Cell Lung...	lisinopril placebo	18 Years -	Mayo Clinic
Lisinopril or Coreg CR® in Reducing Side Effects in Women With Breast Cancer Receiving Trastuzumab	NCT01009918	Breast Cancer Cardiac Toxicit...	Coreg CR® lisinopril placebo	18 Years -	University of South Florida
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

Spots Global Cancer Trial Database for lisinopril

Every month we try and update this database with for lisinopril 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 lisinopril

Every month we try and update this database with for lisinopril 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 lisinopril 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.