Cognitive Effects of Interferon in Patients With Melanoma

A Pilot Study of Neurocognitive Function in Patients Treated With Adjuvant Interferon Alpha-2b for High-Risk Melanoma

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02074605

Enrollment

Registered

2014-02-28

Start date

2008-07-31

Completion date

2010-05-31

Last updated

2014-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

Keywords

Melanoma, Interferon, Cognition

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.

Interventions

BIOLOGICALInterferon alpha

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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 60. * 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.

Design outcomes

Primary

Measure	Time frame	Description
Change in cognitive function	1 month	Cognitive function as assessed by a brief neurocognitive testing battery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026