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Active Not Recruiting NCT03079999

Study of Aspirin in Patients With Vestibular Schwannoma

Conditions: Vestibular Schwannoma, Acoustic Neuroma, Neurofibromatosis 2

Sex: All
Ages: 12 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 97
Sponsor: Massachusetts Eye and Ear Infirmary

Location: Stanford Otolaryngology/HNS Stanford California

Summary

This is a phase II prospective, randomized, double-blind, longitudinal study evaluating whether the administration of aspirin can delay or slow tumor growth and maintain or improve hearing in VS patients.

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT03079999). StuddyBuddy aggregates publicly available trial information.