N/A
Completed N=50
A Study to Compare Quality of Life and Compliance in Patients Receiving High-dose Interferon Versus Pegylated Interferon in Patients With Surgically Resected Melanoma
Source: ClinicalTrials.gov NCT01986712 ↗Enrolled (actual)
50
Serious AEs
20.0%
Results posted
Feb 2025
Primary outcomePrimary: Evaluate Compliance With Standard High Dose Interferon (HDI) Versus Sylatron — 10; 38 number of doses taken
Summary
To evaluate the compliance with and perceptions of treatment, as well as health-related quality of life (HRQOL) in surgically resected melanoma patients undergoing HDI or PEG IFN therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluate Compliance With Standard High Dose Interferon (HDI) Versus Sylatron |
10; 38 | — |
| SECONDARY Compare Quality of Life (Qol)for Patients on HDI Versus PEG IFN |
9; 4; 18; 11; 15; 9 | — |
| SECONDARY Assess the Frequency of Grade 3 and Grade 4 Toxicities |
74; 5 | — |
| SECONDARY Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN |
72.9; 71.4; 18.2; 28.6; 9.1; 0.0 | — |
| SECONDARY Treatment-Related Side Effects Impacting Health-Related Quality of Life (FACT-BRM) |
28.5; 21; 60.5; 46.5; 57; 48 | — |
Eligibility Criteria
Inclusion Criteria
- Patient is male or female at least 18 years of age
- Patient has had surgically resected melanoma and plans to receive adjuvant therapy with HDI or PEG IFN
- Patient is willing and able to give written informed consent
- Patient is willing to comply with all study requirements
Exclusion Criteria
- Patient is unable or unwilling to complete QoL questionaire or compliance diary
- Patient has a history of anaphylaxis due to any interferon alpha product
- Patient has autoimmune hepatitis
- Patient has decompensated liver disease (Child-Pugh score>6 ( Class B and C)
- Patient has a history of neuropsychiatric disorder (including depression) that, in the judgment of the investigator, may impair the patient's ability to successfully complete treatment or protocol-related requirements
Data sourced from ClinicalTrials.gov (NCT01986712). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.