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

NCT01880528 | Completed Phase 2 Results DMC

• 4 other identifiers: MC1221NCI-2013-0113912-008062P30CA015083
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 3

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 therapy in patients with lung cancer.

Conditions

Dyspnea; Non-small Cell Lung Cancer; Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  Up to 3 months post-radiation therapy

Secondary Outcomes (4)

• 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)

  Up to 3 months post-radiation therapy

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

  At Week 4

• 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

  At Week 4

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

  At Week 4

Study Arms (2)

Arm I (lisinopril)

EXPERIMENTAL

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

Drug: lisinopril

Arm II (placebo)

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

lisinopril DRUG

Given PO

Also known as: Prinivil, Zestril

Arm I (lisinopril)

placebo DRUG

Given PO

Also known as: PLCB

Arm II (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Dyspnea; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Interventions

Lisinopril

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases

Intervention Hierarchy (Ancestors)

Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Terence T Sio, MD, MS
• Organization: Mayo Clinic

Sio.Terence@mayo.edu

480/301-7050

Study Officials

• Robert Miller, M.D.

  Mayo Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2013
• First Posted: June 19, 2013
• Study Start: May 31, 2013
• Primary Completion: June 5, 2013
• Study Completion: January 29, 2019
• Last Updated: January 2, 2020
• Results First Posted: September 17, 2019

Record last verified: 2019-12

Locations

US (3)