Study of Aspirin in Patients With Vestibular Schwannoma

Launched by MASSACHUSETTS EYE AND EAR INFIRMARY · Mar 9, 2017

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ClinConnect Summary

This clinical trial is studying whether taking aspirin can help slow down the growth of vestibular schwannomas, which are tumors that can affect hearing and balance. The study is for patients diagnosed with these tumors, whether they are related to a condition called Neurofibromatosis 2 or not. Researchers want to see if aspirin can maintain or even improve hearing for patients while keeping track of the tumor's size over time.

To participate in this trial, you need to be at least 12 years old and have a confirmed diagnosis of vestibular schwannoma. You'll also need to be able to take tablets and give your consent to join the study (or have a parent or guardian do it for you if you're under 18). Participants will be randomly assigned to either receive aspirin or a placebo (a non-active pill) and will be monitored over time with regular check-ups, including MRI scans to measure the tumors. It's important to note that this study is currently recruiting participants, and certain factors, like recent use of aspirin or specific medical conditions, may prevent someone from joining.

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Eligibility criteria

• Inclusion Criteria:
• • Radiographic diagnosis of vestibular schwannoma (NF2-associated or sporadic).
• • Age≥12 years.
• • Ability to provide informed consent.Pediatric patients must provide assent in addition to their parents'/guardians' consent. Adult patients who cannot consent for themselves will not be eligible to participate in this study.
• • Ability to swallow tablets.
• Exclusion Criteria:
• • Inability to perform volumetric measurements of vestibular schwannoma(s).
• • Inability to tolerate MRI with contrast.
• • Daily use of aspirin within the last two months. Occasional use of aspirin for pain relief is not exclusionary.
• • Known allergy to aspirin.
• • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of aspirin.
• • Pregnant or lactating women.
• • Patients with serious medical illnesses (e.g. severe asthma) that in the option of the investigator could prevent participation in the trial.
• • Active bleeding diathesis.
• • Hydrocephalus from brainstem compression.
• • Febrile illness or flu-like illness in children and adolescents less than 18 years of age.