Study of Aspirin in Patients with Vestibular Schwannoma
Sponsored by Massachusetts Eye and Ear Infirmary
Dr. Konstantina Stankovic
*Please note: Study participants will have to physically come to a participating center every 6 months for 3 years (7 visits).
What is the purpose of this study?
The purpose of this study is to see if aspirin will prevent tumor growth compared to placebo in patients with sporadic or NF-2 related vestibular schwannoma.
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: Barrow Neurological Institute in Arizona, Mass Eye and Ear, MGH, 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 daily placebo (a pill that will look like aspirin, but is inactive). Randomization means that you or your study doctor will not get to choose whether you get aspirin or placebo. You and your study doctor will also not know whether you are on aspirin or placebo.
During the study, you will come see your study doctor and have an MRI and a hearing test every 6 months. You will also be asked to fill out questionnaires about how vestibular schwannoma impacts your quality of life. You will answer these questions two times 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 will enter the follow up portion of the study. If it turns out you were given placebo during the randomized portion of the study, you will get aspirin until your tumor grows again.
Everyone will be followed on study for at least 3.5 years.
Would the study cover the cost of treatment?
The study treatment (aspirin or placebo) 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 very 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, Odeta Dyrmishi, Odeta_Dyrmishi@MEEI.HARVARD.EDU if you have any questions. You can also contact the site closest to you.
How do I participate?
Please contact one of the following sites to arrange an appointment:
Dr. Konstantina Stankovic or Dr. Brad Welling
Mass Eye and Ear: 617-573-3972
Dr. Scott Plotkin
Dr. Robert Jackler
Dr. Marlan Hansen
University of Iowa: 800-777-8442
Dr. Brian Neff
Mayo Clinic: 507-284-2511
Dr. Clough Shelton
University of Utah: 801-587-8368