Lisinopril in Reducing Shortness of Breath Caused by Radiation Therapy in Patients With Lung Cancer
Condition: Dyspnea; Non-small Cell Lung Cancer; Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma; Dyspnea
Intervention: lisinopril; placebo
Intervention description: Given PO; Given PO
Intervention MeSH terms: Lisinopril
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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 therapy in patients with lung cancer.
    

Eligibility criteria:

        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