Know Cancer

forgot password

Side-effect Management for Patients With Malignant Melanoma Undergoing Treatment With Interferon Alpha (IFN-α)- Diagnosis and Therapy -

18 Years
Open (Enrolling)
Malignant Melanoma

Thank you

Trial Information

Side-effect Management for Patients With Malignant Melanoma Undergoing Treatment With Interferon Alpha (IFN-α)- Diagnosis and Therapy -

Today, the consideration of the side effects of intensive treatment measures and their
influence on quality of life are regarded as standard procedures in oncology. Quality of
life measurements have found their way into clinical studies as patient-reported outcomes.
In comparison to other tumor types, the field of dermato-oncology has had less research
activity concerning quality of life. However, in recent years more attention has been paid
to health related quality of life in malignant melanoma patients, especially under adjuvant
treatment with interferon-alpha. Data about high dose IFN-α treatment, especially from the
USA, show that there are significant physical and psychological side effects, such as
fatigue and depression, which often lead to dosage reduction or termination of treatment. As
yet, there are very few systematic studies about low dose IFN-α treatment, especially in
regard to the side effects during the course of the disease.

Concerning treatment side-effects it is known throughout various areas of oncology that
specific psycho-oncological interventions assist in the patients' adaptation to the illness
and handling of the side effects of therapy.

Inclusion Criteria:

- Documented and proven stage Ib up to stage IIIc malignant melanoma

- No clinical and radiological evidence or suspicion of persistent disease

- Treatment with IFN-α within a study or analog treatment schedule with IFN-α

- ECOG performance status < 2

- Constant after care

- Informed consent to participate in the study

- melanoma diagnosis within the last 5 years or therapy, recurrence or progression
within this period of time.

Exclusion Criteria:

- Inoperable lymph nodes- or distant metastases

- Tumors of other origins or localisations within the past 10 years

- Severe and permanent infectious diseases, e. g. HIV or hepatitis

- Participation in other treatment studies apart from IFN-α

- Insufficient knowledge of German language

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Changes in quality of life

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Katrin Reuter, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Medical Center Freiburg, Department of Psychiatry and Psychotherapy


Germany: Ethics Commission

Study ID:




Start Date:

April 2009

Completion Date:

April 2012

Related Keywords:

  • Malignant Melanoma
  • melanoma
  • interferon-a
  • quality of life
  • psychological distress
  • depressive symptoms
  • side effects
  • Melanoma