A Pilot Study of Neurocognitive Function in Patients Treated With Adjuvant Interferon Alpha-2b for High-Risk Melanoma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Arizona
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Change in cognitive function
Study Overview
Brief Summary
Interferon alpha is the only approved adjuvant biologic therapy for individuals diagnosed with high risk malignant melanoma (stage 2 or 3). There is evidence that interferon has some adverse cognitive effects on patients, but there are limited data. The investigators hypothesis is that compared to patients with melanoma who do not receive interferon, patients who have melanoma and are treated with interferon will show an objective decrease in performance on neurocognitive assessment.
This study will enroll patients with melanoma who qualify for interferon, and either decide to undergo interferon treatment or choose watchful waiting instead. All patients will be assessed with a cognitive testing battery twice. Observation patients will undergo testing at their first appointment in which they consent to the study, as well as at their next physician visit, approximately 3 months from the first visit. Interferon patients will be tested immediately prior to starting interferon, as well as immediately after completing high dose interferon.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients diagnosed with high risk malignant melanoma (defined as American Joint Committee on Cancer Stage IIb or greater) electing to undergo treatment with either adjuvant interferon alpha-2b, or observation only.
- •Age 18 years or older.
- •Karnofsky performance status greater than
- •Fluent English speaker.
Exclusion Criteria
- •History of neurologic or psychiatric disease that will affect patient's ability to complete protocol tests.
- •Clinical or radiological evidence of brain metastasis.
- •Any condition, which in the opinion of the investigator makes the subject unsuitable for study participation.
Outcomes
Primary Outcomes
Change in cognitive function
Time Frame: 1 month
Cognitive function as assessed by a brief neurocognitive testing battery
Secondary Outcomes
No secondary outcomes reported
Investigators
Daniel Combs
Clinical Assistant
University of Arizona