Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Conditions
Brief summary
This study evaluates the impact of immunotherapy on balance in patients receiving immunotherapy as part of their standard of care.
Interventions
OTHERNon-Interventional Study
Non-interventional study
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age at screening * Patients who will be initiating single agent immunotherapy with pembrolizumab, cemiplimab, nivolumab, atezolizumab, or dual therapy with (Ipilimumab/Nivolumab or Nivolumab/Relatlimab)
Exclusion criteria
* Concurrent chemotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in clinically significant vestibulopathy - vestibular function | Baseline, 3 months, 6 months, 12 months | Assessed using standard vestibular function testing. Results will be aggregated to determine overall vestibular function. Results from baseline (prior to initiating immunotherapy) will be compared to results at 3, 6, and 12 months. |
| Change in clinically significant vestibulopathy - hearing level | Baseline,12 months | Assessed using Pure Tone Audiometry, a standard hearing test. Any change from baseline (prior to initiating immunotherapy) to 12 months will be reported. |
| Oscillopsia Severity Questionnaire (OSQ) | Baseline, 3 months, 6 months, 12 months | The OSQ consists of 9 questions to assess visual environment sensation (episodes of oscillopsia). Questions are answered on a 5-point scale: always, often, sometimes, seldom, never. The OSQ is scored by calculating a mean item score, which results in a total score ranging from 1 to 5. A score of 3 or higher indicates moderate to extreme oscillopsia severity. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCarrlene B. Donald, PA-C, MS
Mayo Clinic
Outcome results
None listed