Status:
COMPLETED
Lisinopril in Reducing Shortness of Breath Caused by Radiation Therapy in Patients With Lung Cancer
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Dyspnea
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ther...
Detailed Description
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 patien...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 31 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 29 2019
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01880528
Start Date
May 31 2013
End Date
January 29 2019
Last Update
January 2 2020
Active Locations (3)
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1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
3
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198