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
18 Years
N/A
Both
Dyspnea, Non-small Cell Lung Cancer, Small Cell Lung Cancer
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Outcome Measure:
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
Outcome Description:
Descriptive statistics of frequency (percentage) will be used to summarize adverse event (AE) incidence and severity in the lisinopril and placebo arms separately. Should incidence rates differ between the treatment arms, the Chi-square test may be utilized in an exploratory fashion to further characterize the differences. The difference between the two arms (point estimate and 95% confidence interval) will be reported.
Outcome Time Frame:
Up to 3 months post-radiation therapy
Safety Issue:
Yes
Principal Investigator
Robert Miller, M.D.
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Food and Drug Administration
Study ID:
MC1221
NCT ID:
NCT01880528
Start Date:
May 2013
Completion Date:
Related Keywords:
- Dyspnea
- Non-Small Cell Lung Cancer
- Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Dyspnea
- Lung Neoplasms
- Small Cell Lung Carcinoma
Name | Location |
|---|---|
| Mayo Clinic | Rochester, Minnesota 55905 |
| University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
| Mayo Clinic Scottsdale-Phoenix | Scottsdale, Arizona 85259 |
