Quality-of-Life Assessment for Lung Cancer

Phase-Based Estimates
1
Effectiveness
2
Safety
M D Anderson Cancer Center, Houston, TX
Lung Cancer+13 More
Quality-of-Life Assessment - Other
Eligibility
18+
All Sexes
Eligible conditions
Lung Cancer

Study Summary

This study is evaluating whether a medication may help prevent lung cancer in individuals with high risk nodules.

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Eligible Conditions

  • Lung Cancer
  • Lung Neoplasms
  • Stage II Lung Cancer AJCC v8
  • Stage IA3 Lung Cancer AJCC v8
  • Stage IIB Lung Cancer AJCC v8
  • Stage IA1 Lung Cancer AJCC v8
  • Stage III Lung Cancer AJCC v8
  • Stage IA2 Lung Cancer AJCC v8
  • Stage I Lung Cancer AJCC v8
  • Lung, Carcinoma
  • Stage IB Lung Cancer AJCC v8
  • Stage IIIC Lung Cancer AJCC v8
  • Stage IIA Lung Cancer AJCC v8
  • Stage IIIB Lung Cancer AJCC v8
  • Stage IIIA Lung Cancer AJCC v8

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Quality-of-Life Assessment will improve 1 primary outcome and 4 secondary outcomes in patients with Lung Cancer. Measurement will happen over the course of Baseline and 24 weeks.

Month 7
Regression of indeterminate pulmonary nodules (IPNs)
Baseline and 24 weeks
Quality of life questionnaires
Up to 24 weeks
Incidence of adverse events
Incidence of lung cancers
Lung cancer-free survival

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
Prevention (canakinumab)

This trial requires 50 total participants across 2 different treatment groups

This trial involves 2 different treatments. Quality-of-Life Assessment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Prevention (canakinumab)Patients receive canakinumab SC on day 1. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Canakinumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 7 months after treatment
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly at 7 months after treatment for reporting.

Closest Location

M D Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients with history of stage I-III NSCLC, who have completed treatment with curative intent, who have persistent IPNs (on two CT scans at least 3 months apart with no evidence of shrinkage or regression) with > 30% cancer probability by Brock University cancer prediction equation, but biopsy showed no clear evidence of malignancy
A male participant must agree to use a contraception during the treatment period plus an additional 6months (a spermatogenesis cycle) after the last dose of study treatment and refrain from donating sperm during this period
Patients with history of stage I-III non-small cell lung cancer (NSCLC), who have completed treatment with curative intent, who have persistent IPNs (on two CT scans at least 3 months apart with no evidence of shrinkage or regression) with 5-30% cancer probability by Brock University cancer prediction equation as following
At least 18 years of age on the day of signing informed consent
Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 6 months after study treatments with risk of genotoxicity after the last dose of study treatment
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the start of study treatment
Absolute neutrophil count (ANC) >= 1500/uL (collected within 10 days prior to the start of study treatment)
The participant (or legally authorized representative if applicable) provides written informed consent for the trial
Patients with no history of lung cancer, who have persistent IPNs (on two computed tomography [CT] scans at least 3 months apart with no evidence of shrinkage or regression) detected by low dose computed tomography [LDCT]-guided lung cancer screening or imaging studies for other reasons (incidentalomas) with 10-30% cancer probability by Brock University cancer prediction equation as following
Patients with no history of lung cancer, who have persistent IPNs (on two CT scans at least 3 months apart with no evidence of shrinkage or regression) detected by LDCT-guided lung cancer screening or imaging studies for other reasons (incidentalomas) with > 30% cancer probability by Brock University cancer prediction equation as following, but biopsy showed no clear evidence of malignancy

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can lung cancer be cured?

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A cure for lung cancer may be possible, but unlikely given that its biology is such that cure appears to be unlikely in any individual case.

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What is lung cancer?

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Lung cancer is a disease that forms in the cells in the lungs, is characterized primarily by a growth of abnormal cells, and causes cells to grow and spread uncontrollably. In 2013 lung cancer resulted in about 467,000 deaths in the US. It is the number one cause of death from cancer among people aged 45 and over, and the 5th most common cause of cancer mortality overall. Smoking is an important risk factor in the development of lung cancer.

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What are the signs of lung cancer?

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Symptoms of lung cancer include shortness of breath when lying flat, cough or weight loss. These may be not noticeable or only reported by the person in question if they have had lung cancer before. There may be an unexplained raised sedimentation rate. A cough lasting over a fortnight may in an elderly person indicate lung cancer. A small lump in the throat may prompt a further referral. It is also not uncommon for people with lung cancer to complain of chest pain. Some people with lung cancer may just have pleurisy or interstitial lung disease.

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How many people get lung cancer a year in the United States?

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The average number of patients diagnosed with lung cancer is around 5,900 annually. In recent years, rates have been increasing in all states, but these increases appear to be due to increases in the average number of patients diagnosed because improvements in detection and/or treatments have been insufficient. It is unclear at what level these increases are due the most—either population level increases or changes in the stage at which lung cancer is diagnosed.

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What causes lung cancer?

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The causes of [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer)s may include cigarette smoking and radon exposure. Smoking is strongly linked to the risk for both lung cancer and cancers of the lungs that respond better to tobacco treatments. In areas with widespread radon exposure, the risk increases substantially with increasing level of exposure, and in areas where radon exposure occurs by breathing the air in areas of high concentrations, the risk increases with time of exposure. People with lung cancer who are heavy smokers have a higher risk of lung cancer, and lung cancer is more common among men than among women. Both viral infection and genetic changes in the immune system have been proposed as explanations for cancer development. The role of inhaled toxins and the role of viruses in cancer have not been clearly established.

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What are common treatments for lung cancer?

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Most physicians are familiar with many of the treatments for localized and advanced lung cancer, but there remains room for more effective treatment and improved knowledge in managing lung cancer.

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What is the latest research for lung cancer?

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There are many types of treatment available that have shown efficacy for delaying or halting the spread of lung cancer. They include systemic chemotherapy, radiation, biologic therapies (i.e. drugs), surgical resection and targeted therapy. Recently, the use of targeted therapies has been very successful in slowing down the disease. For small cell lung cancer, targeted treatment with a small molecule inhibitor of epidermal growth factor receptor has been shown to enhance the efficacy of chemotherapy. In addition to the advances in pharmaceutical treatment for lung cancer, there are also many advances in surgical treatment of lung cancer. One of the most important advances has been the introduction of lobectomy in lieu of complete pneumonectomy if the condition is optimally controlled by chemotherapy.

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What does quality-of-life assessment usually treat?

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Quality of life improvement may be the most important benefit of treatment. Physicians caring for patients with lung cancer have a responsibility not only to optimize treatment but also to reduce side effects.

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Has quality-of-life assessment proven to be more effective than a placebo?

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QOL assessments are more effective than a placebo among both patients with advanced or recurrent lung cancer and their caregivers, and appear to improve both patient and caregiver QOL. QOL assessments will continue to occupy the primary role in lung cancer clinical trials.

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Is quality-of-life assessment safe for people?

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There is high-quality evidence that the EQ-5D-5L questionnaire is valid to be used as a proxy HRQoL assessment in people with lung cancer and that it is a useful tool for assessing HRQoL in people. The data from this meta-analyses should help health professionals to decide the questionnaires that will best support patient decisions about treatment options.

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What are the common side effects of quality-of-life assessment?

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In our study, most respondents found quality of life assessments to be helpful in decision making on treatment. Although side effects are common, they do not hinder the decision making process. The most troublesome side effects are dysphagia, hypoalbuminemia, weight loss, and low self-esteem. For healthcare providers and their patients, QoL assessments are helpful in deciding treatment and in evaluating the treatment's outcomes, and it is also an important strategy to help patients with lung cancer live as much as possible, in spite of side effects.

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Have there been any new discoveries for treating lung cancer?

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There have been a number of new therapies for treating the lung cancer. However, many of those therapies are experimental, or not yet proven to be safe, in clinical practice. These include inhibitors of vesicles trafficking proteins and angiogenesis inhibitors. The angiogenesis inhibitors and VEGF/VEGFR specific drugs may also be used in adjuvant or neo adjuvant therapy for NSCLC. The role of VEGF/VEGFR inhibitors was further elucidated in a trial presented at the American Thoracic Society Meeting entitled ‘ Vascular Endothelial Growth Factor Inhibitor In Clinical Practice.

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