Study of Aspirin in Patients With Vestibular Schwannoma

Last updated: December 16, 2025
Sponsor: Massachusetts Eye and Ear Infirmary
Overall Status: Active - Not Recruiting

Phase

2

Condition

Hearing Impairment

Hearing Loss

Vestibular Hypofunction

Treatment

Placebo

Aspirin

Clinical Study ID

NCT03079999
17-030
W81XWH-17-1-0644
  • Ages > 12
  • All Genders

Study 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

Inclusion Criteria:

  • Radiographic diagnosis of vestibular schwannoma (NF2-associated or sporadic).

  • Age≥12 years.

  • Ability to provide informed consent.Pediatric patients must provide assent inaddition to their parents'/guardians' consent. Adult patients who cannot consent forthemselves will not be eligible to participate in this study.

  • Ability to swallow tablets.

Exclusion

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 painrelief is not exclusionary.

  • Known allergy to aspirin.

  • Impairment of gastrointestinal function or gastrointestinal disease that maysignificantly alter the absorption of aspirin.

  • Pregnant or lactating women.

  • Patients with serious medical illnesses (e.g. severe asthma) that in the option ofthe 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 yearsof age.

Study Design

Total Participants: 97
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
June 11, 2018
Estimated Completion Date:
February 28, 2029

Study Description

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. In the Randomized Treatment Phase, patients aged 12 years or older with VSs will be identified and recruited into one of two randomized groups who receive either 1) 325 mg aspirin twice daily (81 mg aspirin twice daily for pediatric patients <50 kg); or 2) a placebo. Patients will stay on aspirin/placebo as long as there is no more than 20% increase in VS volume. At tumor progression, patients will enter the Open Label Follow Up Phase. Patients who progress on placebo will be given the option to receive unblinded aspirin and will be followed until further progression, receiving a definitive treatment (e.g, surgery or radiation), or 42 months post-baseline, whichever occurs first. Patients who progress on aspirin (either blinded or unblinded) will be taken off study drug and followed until they receive a definitive treatment (e.g., surgery or radiation) or reach 42 months post-baseline, whichever comes first.

Connect with a study center

  • Stanford Otolaryngology/HNS

    Stanford, California 94304
    United States

    Site Not Available

  • Stanford Otolaryngology/HNS

    Stanford 5398563, California 5332921 94304
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33136
    United States

    Site Not Available

  • University of Miami

    Miami 4164138, Florida 4155751 33136
    United States

    Site Not Available

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Massachusetts Eye and Ear

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Massachusetts Eye and Ear Infirmary

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Massachusetts Eye and Ear

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Mayo Clinic

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84101
    United States

    Site Not Available

  • University of Utah

    Salt Lake City 5780993, Utah 5549030 84101
    United States

    Site Not Available

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