RecruitingNot ApplicableNCT06985056

Reducing Symptom Burden Through Physical Exercise in Melanoma Patients

Reducing Symptom Burden Through Physical Exercise in Melanoma Patients Under Immuno- or Targeted Therapy


Sponsor

Universität Duisburg-Essen

Enrollment

104 participants

Start Date

Aug 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether a structured physical exercise program can reduce symptoms and side effects in melanoma patients who are receiving immune therapy or targeted therapy after surgery. **You may be eligible if...** - You are 18 or older with malignant melanoma (Stage IIb–IV) - You are currently receiving adjuvant immunotherapy or targeted therapy - You have been on the same treatment for at least 3 months - You understand German (the program is conducted in German) - Your doctor has approved you for exercise - You are able to travel to the study hospital for training sessions **You may NOT be eligible if...** - Your doctor has identified reasons you should not exercise (e.g., fracture risk from bone metastases) - You have untreated or symptomatic brain metastases - You have severe neurological or heart problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALSupervised 12-week Resistance and Endurance Exercise Program

60 Minute home-based and supervised endurance, resistance and coordination training 2x/week for 12 weeks, self-administered 20 minute home-based multimodal training 1x/week


Locations(1)

University Hospital Essen

Essen, Germany

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NCT06985056


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