Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06985056

Reducing Symptom Burden Through Physical Exercise in Melanoma Patients

Led by Universität Duisburg-Essen · Updated on 2026-03-27

104

Participants Needed

1

Research Sites

115 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The aim of the clinical trial is to determine whether regular exercise can reduce fatigue in adult patients with stage IIb-IV melanoma undergoing immunotherapy or targeted therapy. Additionally, we will investigate whether a supervised exercise program improves patients' quality of life, cognitive skills, and physical fitness compared to a control group without structured exercise. We will also examine other health outcomes and various blood parameters, such as interleukins and metabolites, to understand how regular activity can affect metabolism and immune function. After the initial assessment at the clinic, patients will be randomly assigned to two groups. Those in the intervention group will participate in a 12-week exercise program, which includes a 60-minute personalized and supervised online training session twice a week. In weeks 3, 6, and 9, one training session will be held at the clinic. Furthermore, patients in the intervention group are encouraged to complete a self-administered 20-minute exercise session once a week. The control group will not receive a supervised exercise program. Following the 12-week intervention period, another assessment will be conducted at the clinic. All patients will then enter a 6-week follow-up phase, during which neither group will receive supervised exercise training. After this follow-up phase, a final assessment of all outcomes will take place at the clinic.

CONDITIONS

Official Title

Reducing Symptom Burden Through Physical Exercise in Melanoma Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 18 years or older with malignant melanoma (Stage IIb - IV) receiving adjuvant or palliative immunotherapy or targeted therapy
  • Patients with ECOG performance status level 0-2
  • Patients on the same treatment protocol for at least 3 months and no more than 9 months
  • Sufficient knowledge of German language
  • Completed and signed written consent and medical history forms
  • Medical clearance for exercise program and performance diagnostics
  • Ability to participate in the exercise program
  • Willingness to visit the study hospital for training sessions and examinations
Not Eligible

You will not qualify if you...

  • Contraindications for physical exercise confirmed by physician (e.g., fracture risk from bone metastases)
  • Untreated, symptomatic, known brain metastases
  • Severe neurological or cardiac impairment per ACSM criteria
  • Physician-confirmed respiratory insufficiency
  • Life expectancy less than 3 months
  • Physical or mental conditions preventing exercise program or study participation
  • Excessive physical activity (>150 minutes/week moderate to intense activity or intense strength/endurance training twice weekly for at least one hour)

AI-Screening

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Trial Site Locations

Total: 1 location

1

University Hospital Essen

Essen, Germany, 45147

Actively Recruiting

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Research Team

S

Simon Basteck, M.Sc.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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