Lung Health Study
What is the Study About?
The Lung Health Study is a clinical arm of the Cancer Imaging Department at the BC Cancer Research Centre. The primary focuses of the Lung Health Study are the early detection of lung cancer and chemoprevention trials. If lung cancer is diagnosed in its early stages it significantly improves the survival rate. Individuals which qualify for our current chemoprevention studies will be screened for precancerous changes. If these precancerous changes are found in the lung as a result of the screening, patients are offered the opportunity to take part in one of the chemoprevention trials.
Chemoprevention Clinical Trials
Chemoprevention is the use of natural or laboratory-made substances to cancer. Chemoprevention trials are designed to study the ability of certain compounds to stop or reverse the progression of early cell changes in the lung. Once a participant meets the eligibility criteria for a specific study, they will be asked to take the trial medication for a period of time. The time period can vary from one to six months depending on the study. At the end of treatment period, fluorescence bronchoscopy will be repeated to determine the effectiveness of the study medication.
If you choose to take part in a chemoprevention study you will be asked to arrange monthly appointments with study staff in Vancouver. Other tests may be required such as: carbon monoxide monitoring and, regular blood tests in order to monitor any potential side-effects from the study medication.
Eligibility
The Lung Health Study is currently recruiting volunteers for the Green Tea and Symbicort Studies. If you:
-Are an ex-smoker
-Are a resident of British Columbia
-Are 45-74 years of age
-Have smoked for at least 30 years or more
-Are not currently undergoing chemotherapy or radiation therapy...
You may be eligible for one of the studies!
Current Chemoprevention Studies
Green Tea
Research in the last several decades suggest that consuming 10 cups of more of Japanese style green tea a day may reduce the risk of lung and other cancers. However, no definitive conclusion could be drawn from the studies, as there has not been a study using a standardized green tea preparation and compare its health benefits with a placebo (an inactive substance that looks like the active compound). Consuming large amounts of caffeinated tea may also result in sleeplessness or palpitation of the heart. The health benefits of consuming large amounts of decaffeinated green tea are not known.
The purpose of this study is to find out if a standardized preparation of decaffeinated green tea called Polyphenon E may have some effect on healing pre-cancerous changes in former heavy smokers at risk of developing lung cancer.
During this study you will see the study therapist once a month for the next 6 months. During each visit, you will be asked a set of questions. These questions help us find out if you have any symptoms or events that might be related to side effects of the extract. Blood tests will also be taken to monitor for any potential side effects.
At the end of six months, a sputum test and bronchoscopy will be repeated. This comparison will help us understand if the study drug works.
Sulindac
Sulindac is a drug which has been approved by the FDA and Health Canada for the treatment of osteoarthritis and rheumatoid arthritis as well as for acute painful shoulder and acute gouty arthritis.
This study is being done to find out what effects, Sulindac (Clinoril) has on you and your risk of developing lung cancer. Currently there are no established guidelines for observing pre-cancerous changes in the airways.
Symbicort
Symbicort is an approved, inhaled prescription drug for the treatment of asthma. It is a combination of two medications, Budesonide and Formoterol. Budesonide helps to settle the inflammation. Formoterol relieves the bronchospasm and help to clear mucus from the bronchial tubes.
There is increasing evidence that inflammation over a long period of time may play an important role in the development of cancers including lung cancer. The purpose of the study is to determine if there is a connection between COPD(Chronic Obstructive Pulmonary Disease) progression and the development of lung cancer as well as examining the effects of anti-inflammatory medicine (ex Symbicort) on improving health outcomes.
During this study you will be enrolled and taking Symbicort for a period of one month. At the end of one month, the breathing test, blood test and bronchoscopy will be repeated to find out how well the Symbicort Turbuhaler works.
Study Sign-up
If you are interested in participating in the Green Tea, Sulindac or Symbicort studies you can complete a questionnaire
through the internet or by calling us at the study office.
Vancouver: 604-675-8088 or 1888-675-8001 ext 8088
Victoria: 250-519-5720 or 1800-670-3322 ext 5770
Internet
You will need to print this questionnaire and mail or fax it back to us. Unfortunately, due to confidentiality concerns the questionnaire cannot be sent over the internet. We apologize for any inconvenience. After receiving your questionnaire a member of the study team will respond with further information over the phone.
Download:
Lung Health Study Questionnaire
Phone
The study team is happy to answer any questions that you may have concerning our research programs. As a result of enthusiastic support from individuals such as yourself it is not always possible to answer each call immediately. if you are unable to contact a member of the study team directly please leave us a message and we will return your call as soon as possible.
Why is the study being done?
The risk of lung cancer in smokers is well recognized. Although the risk of lung cancer is lower in a former smoker compared to a current smoker, the risk of lung cancer decreases very slowly in long-term heavy smokers despite smoking cessation. At present, 50% of new lung cancer cases are former smokers, many of whom have already given up smoking for several years. Therefore, even in former smokers, an additional strategy is needed to reduce the risk of lung cancer. New approaches such as early detection of cancer or cancer prevention need to be further explored.
Lung cancer usually occurs after years of exposure to tobacco smoke and other substances. During this time the normal cells lining the air passages of the lungs undergo changes. These changes can gradually become more severe with time and may ultimately progress to invasive lung cancer. Chemoprevention or bioprevention refers to the use of natural or man-made compounds to prevent cancer. These preparations reverse or stop the development of pre-cancerous changes (dysplasia). These are areas that may turn into cancer with time. Various substances are being studied to prevent lung cancer. To test these compounds, it is necessary to identify people with pre-cancerous changes. Not everyone who smokes or used to smoke heavily develops pre-cancerous changes in their air passages.
What's Involved?
Your first visit with us will take approximately 2½ hours. At this time study staff will explain the study to you in detail, obtain a smoking and medical history and ask for your consent to participate in the study. Depending on the study a number of tests can also be completed at this first visit. A blood sample will be obtained to measure an inflammation marker called C-Reactive Protein (CRP) to assess lung cancer risk. A breathing test will then be done to measure your lung function. A sputum(mucus) test will be completed. For this test you will be asked to breathe a vaporized sea water mist while wearing a vibrating vest, which will assist in loosening secretions in your lungs. We will then have you do some deep coughing so that we are able to obtain a sputum sample.
Your sputum sample will be examined by a micro-imager which will scan the sample looking for any abnormal cells. You will be contacted with the results of your sputum test. If there are any abnormal cells in your sputum you will be given the option of participating in the next part of the study.
A CT scan may also be offered and arranged on a seperate day. Spinal CT looks at the lungs from top to bottom in very thin slices, which makes it possible to see nodules as small as 1mm. Depending on the results of these tests you may be offered a bronchoscopy
Bronchoscopy
A bronchoscopy is a standard diagnostic procedure for examination of the major airways of the lungs. The bronchoscopy will be done with mild sedation and local anesthetic and is concluded in about 30 minutes. In total you will spend approximately 3 ½ hours at the BC Cancer Agency (BCCA) on the day of your procedure. A bronchoscopy is a safe diagnostic procedure in trained hands and carries little risk.
The exam is done with localized freezing to your throat. An intravenous will be started to keep you well hydrated. You will be given a mild sedative (Midazolam) to help you relax and also a short acting narcotic (Alfentanil) will be given during the procedure to help with the cough. Due to the sedation used during the procedure you are considered legally impaired for rest of the day and therefore will require another adult to escort you from the BCCA.
Your airways will first be examined using a blue light and then with a white light. Under the blue light abnormal areas in your airways can be easily visualized compared to white light. If any abnormal sites are observed, a tiny tissue sample or biopsy will be taken for examination by a pathologist. We will contact you with the results of your bronchoscopy.
Spinal CT
Spinal CT(computed tomography) scans are performed as a part of the Lung Health Study to asses the role it may play in screening for early lung cancer. There are a number of other centres in the world that are also investigating the use of CT scans in this role. A pilot study was completed at the BC Cancer Agency and Vancouver General Hospital between June 200 and June 2002.
What have we learned?
-90% of smokers and ex-smokers who have a chest CT scan will have an "abnormal" CT scan that will require follow up.
-These abnormalities appear as small rounded dots (nodules) and/or small fluffy patches called ground glass opacities on the chest CT
-The CT scan cannot tell us exactly what causes these abnormalities but we know that about 99% will be benign (non-cancerous) . They may be due to scars, lymph nodes or small ares of inflammation
-These abnormalities are usually very small (<10mm) and therefore cannot be biopsied. Instead we will watch with repeat CT scans to make sure they don't start to grow
-We will arrange 2-3 follow up CT scans at Vancouver General Hospital over two years if there are any of these nodules or soft patches present on your screening CT scan.
-If there is a large abnormality (>10 mm) on the screening CT scan or if a small nodule starts to grow, then we will arrange appropriate investigation and treatment for you.
Upcoming Studies
There are two upcoming studies, Myo-Inositol and the Pan Canadian Study. Myo-Inositol is a chemoprevention study to determine its effects on reducing lung cancer incidence. Pan Canadian study will try to determine what risk factors are most significant in determining whether an individual will have the greater risk for developing lung cancer. Further information will be posted when the study opens for enrollment.
Smoking Cessation
If you are currently smoking, as health care professionals, our primary concern is providing you with the resources to stop smoking.
If you would like further assistance in quitting, please contact out smoking cessation nurse, Suzan Ross at 604 675 8088 or sross@bccancer.bc.ca.
Further Links
BC Lung Association -
www.quitnow.ca
Study Team
- Dr Stephen Lam, MD, FRCPC, Respirologist and Head of the Lung Cancer Prevention Program
- Dr Annette McWilliams, MD, FRCPC, Respirologist
- Sharon Gee, Project Coordinator
- Suzan Ross, RN
- Myles McKinnon, Respiratory Therapist
- Bimmie Kalan, Respiratory Therapist
- Jamie Best, Interviewer
Contact Information
For further information please call us:
Vancouver: 604-675-8088 or 1888-675-8001
Victoria: 250-519-5720 or 1800-670-3322