Trials & StudiesThe TRAIL Trial: A Research Study for Postmenopausal Women with Lymphangioleiomyomatosis (LAM)What is the purpose of this study?The TRAIL (Trial of Aromatase Inhibition in Lymphangioleiomyomatosis) Trial is a research study to find out if a medication called letrozole slows the rate of decline in lung function in women with Lymphangioleiomyomatosis (LAM) when compared to a placebo. Letrozole is approved by the United States Food and Drug Administration to help prevent recurrence of breast cancer. The use of letrozole to treat LAM is experimental and has not been approved by the FDA. Who will be included in this study?Women 18 years and older who have LAM and are postmenopausal may be eligible to participate. What is involved?Women who enroll in the study will be involved for about one year. Participants will take either letrozole or a placebo every morning. Those who are eligible to participate will be “randomized” by chance (like flipping a coin) into two groups. One group will receive the study medication; the other, a placebo (an inactive substance that looks like the study medication). There is an equal chance (50-50) of being placed into either group. Neither the study staff nor the study participants will know who is receiving the study medication and who is receiving the placebo.
In addition, participants will be asked to keep records of all medication they take during the study, including their assigned study medication/placebo and any prescription or over-the-counter medications. All study-related medication, tests and exams that are not a normal part of routine care for LAM will be provided at no cost to participants. Tests and exams that are a normal part of routine care for LAM are the participant’s or the participant’s insurances company’s responsibility. What are the benefits?Participants may or may not benefit from participating in this study. Participants may benefit from the physical exams, pulmonary function tests, and other study procedures. Other potential benefits may include stabilization or improvement in lung function, and stabilization or decrease in the size of any kidney tumors or lymphangiomyomas. The information gained from this study may benefit other patients with LAM in the future. Will I get all the facts about the study?Those who are interested in participating will be given a consent form that thoroughly explains all of the details of the study. The form covers all of the procedures, the potential risks and benefits, who to contact with questions or concerns and more. A member of the study staff will review the consent form with participants to ensure all questions are answered. Study procedures will not begin until this form is signed. What are the risks and discomforts of the study?There may be some risks and discomforts, including potentially serious risks, involved with participation in the study. Letrozole is a widely used medication, and the safety profile is well understood. A detailed list of possible side effects will be provided to those interested in knowing more about this study. Where and when will the study be done?The study will be conducted in a subset of LAM Foundation Clinics. Sites for TRAIL will be chosen based on the number of interested and eligible patients in the region and the available resources for trials. The study is expected to enroll the first patient in March 2011 and to conclude in the fall of 2013. Who should I contact for more participant information?Stephanie Hartke, CRC Who should I contact for more Investigator Information?Frank McCormack, MD Genome Wide Association Study (GWAS)The LAM Foundation is excited to help with a very important research project. But we need your help to make this project successful. All you need to do is complete a 1 page questionnaire, sign a consent form, put a saliva sample into a special container that will be sent to you and then send it to the lab. This is all at no cost to you! |