Study of Aspirin in Patients with Vestibular Schwannoma
Sponsored by Massachusetts Eye and Ear
Bradley Welling, M.D., Ph.D.
*Please note: Study participants will come to a participating center on a schedule which matches normal follow-up for patients with vestibular schwannomas under observation. Some visits may be handled virtually.
What is the purpose of this study?
The purpose of this study is to see if aspirin will prevent tumor growth in patients with sporadic or NF-2 related vestibular schwannoma compared to patients who do not take aspirin.
Who qualifies to participate?
Patients who can participate include those with vestibular schwannoma, either sporadic or NF-2 related, aged 12 and older.
What centers are participating in the study?
The centers who are participating are: Mass Eye and Ear, Mayo Clinic, Stanford University, University of Iowa, University of Miami, and University of Utah.
What happens if I agree to participate in the study?
If you agree to participate in the study and are found to be eligible, you would be randomized to receive daily aspirin or no treatment. Randomization means that you or your study doctor will not get to choose whether you get aspirin or not.
During the study, you will have a visit with your study doctor. An MRI and a hearing test are performed at baseline, 6 months after enrollment, and every year you are on the study (5 total).You will also be asked to fill out short questionnaires about how your vestibular schwannoma impacts your quality of life. You will answer these questions at each follow up over the course of the study. We will also draw some blood (about 2 teaspoons each time) to do research on vestibular schwannoma the following times: when you start the study, at 6 months, at 1 year, and every year you are on the study thereafter.
If your tumor grows while you are in the study, you may enter the follow up portion of the study. If it turns out you were not on aspirin during the randomized portion of the study, you have the option to move into the group taking aspirin for further follow up or you may select to leave the study and receive other treatment options such as surgery or radiation.
Everyone will be followed on study for 3.5 years.
Would the study cover the cost of treatment?
The study treatment (aspirin) will be provided to you at no cost to you.
Are there any additional costs or financial benefits to participate in the study?
While you will not be charged for the research blood draws, the rest of the medical care on the study (the study doctor visits, MRIs, and hearing tests) would be done even if you weren’t on the study and will be charged to you or your insurance in the usual way.
You will not be paid if you agree to participate in the study.
Are there any additional risks associated with participating in the study?
Aspirin is a safe and common over-the-counter medication. However, some people have sensitivity to aspirin and should not participate. In addition, a very low percentage (between 1-2%) of people experience minor stomach discomfort from aspirin. An even lower percentage (0.1-0.2%) of people experience more severe symptoms from aspirin such as bleeding, ulcers or stoke. Aspirin use should be avoided in children with flu-like symptoms or fever as it can lead to a very rare disease, with vomiting and mental status changes (Reye’s syndrome).
What if I have other questions?
Please contact the Primary Study Coordinator:
Ali Brown, Alyssa_Brown@MEEI.HARVARD.EDU,
or the Program Manager:
Ellen Fitzgerald, Ellen_Fitzgerald@MEEI.HARVARD.EDU if you have any questions. You can also contact the participating site closest to you.
How do I participate?
Please contact one of the following sites to arrange an appointment:
Bradley Welling MD, PhD
Mass Eye and Ear: 617-573-3632
Konstantina Stankovic MD, PhD
Marlan Hansen, MD
University of Iowa: 800-777-8442
Brian Neff, MD
Mayo Clinic: 507-284-2511
Neil Patel MD or Richard Gurgel, MD
University of Utah: 801-587-8368
Fred Telischi, MD
University of Miami: 305-243-3564