ACTIVE_NOT_RECRUITING

Study of Aspirin in Patients With Vestibular Schwannoma

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Conditions

Vestibular SchwannomaAcoustic NeuromaNeurofibromatosis 2

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Prospective, Randomized, Placebo-Controlled Phase II Trial of Aspirin for Vestibular Schwannomas

Quick Facts

Study Start:2018-06-11
Study Completion:2029-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03079999

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Radiographic diagnosis of vestibular schwannoma (NF2-associated or sporadic).
  2. * Age≥12 years.
  3. * 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.
  4. * Ability to swallow tablets.
  1. * Inability to perform volumetric measurements of vestibular schwannoma(s).
  2. * Inability to tolerate MRI with contrast.
  3. * Daily use of aspirin within the last two months. Occasional use of aspirin for pain relief is not exclusionary.
  4. * Known allergy to aspirin.
  5. * Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of aspirin.
  6. * Pregnant or lactating women.
  7. * Patients with serious medical illnesses (e.g. severe asthma) that in the option of the investigator could prevent participation in the trial.
  8. * Active bleeding diathesis.
  9. * Hydrocephalus from brainstem compression.
  10. * Febrile illness or flu-like illness in children and adolescents less than 18 years of age.

Contacts and Locations

Principal Investigator

Konstantina Stankovic, MD, PhD
PRINCIPAL_INVESTIGATOR
Stanford University
D. Bradley Welling, MD, PhD
PRINCIPAL_INVESTIGATOR
Massachusetts Eye and Ear

Study Locations (Sites)

Stanford Otolaryngology/HNS
Stanford, California, 94304
United States
University of Miami
Miami, Florida, 33136
United States
Massachusetts Eye and Ear
Boston, Massachusetts, 02114
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
University of Utah
Salt Lake City, Utah, 84101
United States

Collaborators and Investigators

Sponsor: Massachusetts Eye and Ear Infirmary

  • Konstantina Stankovic, MD, PhD, PRINCIPAL_INVESTIGATOR, Stanford University
  • D. Bradley Welling, MD, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts Eye and Ear

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-06-11
Study Completion Date2029-02

Study Record Updates

Study Start Date2018-06-11
Study Completion Date2029-02

Terms related to this study

Additional Relevant MeSH Terms

  • Vestibular Schwannoma
  • Acoustic Neuroma
  • Neurofibromatosis 2