Dyspnea | Lisinopril in Reducing Shortness of Breath Caused by Radiation Therapy in Patients With Lung Cancer
Dyspnea research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - Histological confirmation of small cell and non-small cell carcinoma of the lung receiving thoracic radiotherapy > 45 Gy, with volume of lung receiving 20 Gy or more (V20Gy) >= 20% - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2 - Absolute neutrophil count (ANC) >= 1500/mm^3 - Platelet count >= 100,000/mm^3 - Hemoglobin > 9.0 g/dL - Creatinine clearance >= 30 mL/min as calculated using actual body weight and Cockroft Gault formula - Initial physical exam with systolic blood pressure (BP) of > 100 mmHg and diastolic BP of > 60 mmHg - Potassium within institutional normal limits - Sodium within institutional normal limits - Negative pregnancy test done =< 14 days prior to registration, for women of childbearing potential only - Ability to complete questionnaire(s) by themselves or with assistance - Provide informed written consent - Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study) - Willing to provide blood samples for correlative research purposes Exclusion Criteria: - Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - Other active malignancy =< 3 years prior to registration; EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment (e.g., maintenance or adjuvant chemotherapy or hormonal therapy) for their cancer - History of myocardial infarction =< 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias - History of prior radiation therapy treatment to the lungs or thorax - Existing contraindications to angiotensin-converting enzyme (ACE) inhibitors such as hypersensitivity to ACE inhibitors, bilateral renal artery stenosis, angioedema, or previously documented adverse drug reaction to ACE inhibitors - Any of the following: - Pregnant women - Nursing women - Men or women of childbearing potential who are unwilling to employ adequate contraception - Use of ACE inhibitors (including lisinopril) or ACE receptor blockers (ARB) of any kind =< 90 days prior to registration
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Non-small Cell Lung Cancer
Small Cell Lung Cancer
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Arm I (lisinopril)Beginning within 7 days of beginning radiation therapy, patients receive lisinopril PO QD on days 1-7.
Arm II (placebo)Beginning within 7 days of beginning radiation therapy, patients receive placebo PO QD on days 1-7.
Active, not recruiting
Start Date: May 31, 2013
Completed Date: July 1, 2018
Primary Outcome: 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
Secondary Outcome: Incidence of adverse events as measured using the NCI CTCAE version 4.0
Study sponsors, principal investigator, and references
Principal Investigator: Robert Miller, M.D.
Lead Sponsor: Mayo Clinic
Collaborator: National Cancer Institute (NCI)