Clinical trial · Observational
A Study to Compare Quality of Life and Compliance in Patients Receiving High-dose Interferon Versus Pegylated Interferon in Patients With Surgically Resected Melanoma
An Observational Pilot Study to Compare the Compliance With and Health Related Quality of Life During Therapy With Standard High-Dose Interferon Alfa (Intron A, HDI) Versus Pegylated Alfa-Interferon 2b (Sylatron, PEG IFN) in Patients With Surgically Resected Melanoma
NCT01986712CI-TRIAL-00085914completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Intron A, HDI
- description
- High-dose interferon alfa (Intron A, HDI)
- label
- Sylatron
- description
- Pegylated alfa-interferon 2b (Sylatron, PEG IFN)
Primary outcomes (1)
- measure
- Evaluate Compliance With Standard High Dose Interferon (HDI) Versus Sylatron
- timeFrame
- 1 year
- description
- To evaluate compliance with administration of standard HDI versus PEG IFN for patients with surgically resected melanoma in need of adjuvant therapy
Secondary outcomes (4)
- measure
- Compare Quality of Life (Qol)for Patients on HDI Versus PEG IFN
- timeFrame
- baseline -week 1, week 3, week 13, week 25, week 50
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.