DyspneaNCT00880386
Losartan in Treating Pulmonary Fibrosis in Patients With Stage I, II, or III Non-Small Cell Lung Cancer
A study testing Losartan in people with Dyspnea and Lung Cancer, run by University of South Florida.
Trial summary
RATIONALE: Losartan potassium may be effective in treating pulmonary fibrosis caused by radiation therapy in patients with non-small cell lung cancer. PURPOSE: This clinical trial is studying losartan to see how well it works in treating pulmonary fibrosis caused by radiation therapy in patients with stage I, stage… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea, Lung Cancer, Pulmonary Complications
- What is being tested?
- Losartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age or older
- Diagnosed with non-small cell lung cancer stage I, II, IIIa, or IIIb
- Diagnosis of radiation-induced pulmonary fibrosis (as defined by National Cancer Institute's Common Terminology Criteria for Adverse Events [CTCAE] V3.0 Grade I to Grade III) and within 2 years of the last radiation therapy treatment
Who cannot join
- Patients with a pneumonectomy
- Allergy or allergic reaction to Losartan or any other angiotensin II receptor blocker
- Use of an angiotensin II receptor blocker currently or within 6 months of study entry which include: losartan, valsartan, irbesartan, candesartan, cilexetil, eprosartan mesylate, and telmisartan
- Bilateral renal artery stenosis, hereditary or idiopathic angioedema, or uncontrolled hypotension
- Patients taking lithium
- Currently smoking or smoked within 6 months of study entry
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- Pregnant, intending to become pregnant or breastfeeding
- Baseline systolic blood pressure < 100 mmHg
- History of lung transplant
- History of kidney failure or liver disease
- Inability to attend clinic visits
About this study
Official title: A Pilot Project to Determine the Effect of Losartan (Cozaar) on Radiation-Induced Pulmonary Fibrosis in Patients With Non-Small Cell Lung Cancer
RATIONALE: Losartan potassium may be effective in treating pulmonary fibrosis caused by radiation therapy in patients with non-small cell lung cancer.
PURPOSE: This clinical trial is studying losartan to see how well it works in treating pulmonary fibrosis caused by radiation therapy in patients with stage I, stage II, or stage III non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
Primary
- To evaluate the effects of losartan potassium on the disease progression in patients with stage I-III non-small cell lung cancer and radiation-induced pulmonary fibrosis.
- To determine the feasibility of losartan potassium as a possible treatment for radiation-induced pulmonary fibrosis.
Secondary
- The evaluate the effects of losartan potassium on the degree of dyspnea, and lung function (FEV_1 and FVC) in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral losartan potassium once daily for 6 months in the absence of disease progression or unacceptable toxicity.
Patients undergo assessment of pulmonary function (e.g., gas movement, lung capacity, and diffusion of gases) by spirometry and dyspnea by the Visual Analog Scale (VAS) at baseline and at weeks 12 and 24.
- Conditions
- Dyspnea, Lung Cancer, Pulmonary Complications, Radiation Fibrosis
- Being tested
- Losartan
- Keywords
- dyspnea, stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, pulmonary complications, radiation fibrosis
- Medical subject headings
- Dyspnea, Lung Neoplasms, Radiation Fibrosis Syndrome, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LosartanDrug
Also called Cozaar, losartan potassium
50 mg Losartan will be taken daily by subjects for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Losartan Group | Experimental | 50 mg Losartan tablet taken daily for 24 weeks Receives: Drug: Losartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in carbon monoxide diffusing capacity (DLCO) at 6 months
Measured: 6 months
Secondary outcomes (2)
Feasibility of losartan potassium as treatment for radiation-induced pulmonary fibrosis
Measured: 6 months
Pulmonary function measurements of FEV1 and FVC and dyspnea score at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionApr 2010
- Study completionApr 2010
Why it stopped: Study concept was not approved by NCI. Study was never activated. No enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Marisa Couluris, DO, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00880386
- Sponsor's protocol ID
- SCUSF 0208
- Other IDs
- SCUSF-PILOT-0208, HLMCC-PILOT-0208
- Status last verified
- May 2017
- First submitted
- 10 Apr 2009
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Project to Determine the Effect of Losartan (Cozaar) on Radiation-Induced Pulmonary Fibrosis in Patients With Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00880386
- Acronym / sponsor ID
- SCUSF 0208
- Conditions
- Dyspnea, Lung Cancer, Pulmonary Complications, Radiation Fibrosis
- Keywords
- dyspnea, stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, pulmonary complications, radiation fibrosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study concept was not approved by NCI. Study was never activated. No enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 13 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Losartan potassium may be effective in treating pulmonary fibrosis caused by radiation therapy in patients with non-small cell lung cancer.
PURPOSE: This clinical trial is studying losartan to see how well it works in treating pulmonary fibrosis caused by radiation therapy in patients with stage I, stage II, or stage III non-small cell lung cancer.
Detailed description
OBJECTIVES:
Primary
- To evaluate the effects of losartan potassium on the disease progression in patients with stage I-III non-small cell lung cancer and radiation-induced pulmonary fibrosis.
- To determine the feasibility of losartan potassium as a possible treatment for radiation-induced pulmonary fibrosis.
Secondary
- The evaluate the effects of losartan potassium on the degree of dyspnea, and lung function (FEV_1 and FVC) in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral losartan potassium once daily for 6 months in the absence of disease progression or unacceptable toxicity.
Patients undergo assessment of pulmonary function (e.g., gas movement, lung capacity, and diffusion of gases) by spirometry and dyspnea by the Visual Analog Scale (VAS) at baseline and at weeks 12 and 24.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Losartan Group | Experimental | Drug: Losartan50 mg Losartan tablet taken daily for 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years of age or older
- Diagnosed with non-small cell lung cancer stage I, II, IIIa, or IIIb
- Diagnosis of radiation-induced pulmonary fibrosis (as defined by National Cancer Institute's Common Terminology Criteria for Adverse Events [CTCAE] V3.0 Grade I to Grade III) and within 2 years of the last radiation therapy treatment
Key exclusion criteria (11 listed)
- Patients with a pneumonectomy
- Allergy or allergic reaction to Losartan or any other angiotensin II receptor blocker
- Use of an angiotensin II receptor blocker currently or within 6 months of study entry which include: losartan, valsartan, irbesartan, candesartan, cilexetil, eprosartan mesylate, and telmisartan
- Bilateral renal artery stenosis, hereditary or idiopathic angioedema, or uncontrolled hypotension
- Patients taking lithium
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LosartanAlso: Cozaar, losartan potassium50 mg Losartan will be taken daily by subjects for 24 weeks | Drug | Losartan Group |
Primary outcome
Change in carbon monoxide diffusing capacity (DLCO) at 6 months
Time frame: 6 months
2 secondary outcomes
Feasibility of losartan potassium as treatment for radiation-induced pulmonary fibrosis
Time frame: 6 months
Pulmonary function measurements of FEV1 and FVC and dyspnea score at 6 months
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marisa Couluris, DO principal investigator
University of South Florida
Questions about this trial
What is this clinical trial studying?
A study testing Losartan in people with Dyspnea and Lung Cancer, run by University of South Florida.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in carbon monoxide diffusing capacity (DLCO) at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2017.