Regular supervised exercise to reduce symptoms in melanoma
Official title: Reducing Symptom Burden Through Physical Exercise in Melanoma Patients Under Immuno- or Targeted Therapy
Run by Universität Duisburg-Essen · NCT06985056 · Data updated 2026-11-12
This trial tests whether a 12-week supervised exercise program can reduce fatigue and improve quality of life for adults with stage IIb–IV melanoma who are receiving immunotherapy or targeted therapy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 86 (estimated) |
| Sponsor | Universität Duisburg-Essen Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Essen) |
| Status | Recruiting |
| Started | August 18, 2025 |
| Main results expected | September 2027 |
| Study ends | November 2027 |
| Registry record updated | July 8, 2026 |
| Trial ID | NCT06985056 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults (≥18) with stage IIb–IV melanoma receiving adjuvant or palliative immunotherapy or targeted therapy, with ECOG 0–2, on a stable treatment regimen for 3–9 months, who speak German, are medically cleared for exercise, and can attend clinic visits and online sessions.
✕Probably not a fit
Patients with contraindications to exercise (for example untreated symptomatic brain metastases, high fracture risk from bone metastases, severe cardiac or neurological impairment, respiratory insufficiency, or life expectancy under three months) are unlikely to benefit and may be excluded for safety.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with stage IIb–IV malignant melanoma who are on adjuvant or palliative immunotherapy or targeted therapy are randomized after baseline assessment to either a 12-week supervised resistance and endurance exercise program or a control group without structured exercise. The intervention includes two 60-minute personalized online training sessions per week with one in-person training at the clinic in weeks 3, 6, and 9, plus encouragement to perform additional home-based activity. Outcomes include patient-reported fatigue, quality of life, cognitive measures, physical fitness tests, and blood biomarkers such as interleukins and metabolites to explore immune and metabolic effects. The trial requires medical clearance and is conducted at the University Hospital Essen.
Why it matters
Potential benefit: If successful, this could reduce treatment-related fatigue and improve quality of life, cognitive function, and physical fitness for melanoma patients on systemic therapy.
How similar studies have gone: Exercise interventions have reduced cancer-related fatigue and improved quality of life in several tumor types, but supervised exercise specifically during checkpoint inhibitor or BRAF/MEK therapy in melanoma is less well studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients ≥ 18 years with malignant melanoma (Stage IIb - IV) receiving adjuvant or palliative immunotherapy or targeted therapy * patients with ECOG level 0-2 * patients already on the same treatment protocol for at least 3 months and no more than 9 months * sufficient knowledge of German * completed and signed written consent form and completed medical history form * medical clearance for the exercise program and performance diagnostics * ability to participate in the exercise program * willingness to visit the study hospital for training sessions and examinations Exclusion Criteria: * confirmation of contraindications for physical exercise by the attending physician (e.g. fracture risk in the case of bone metastases) * untreated, symptomatic, known brain metastases * severe neurological or cardiac impairment according to ACSM criteria * confirmation of respiratory insufficiency by the attending physician * life expectancy less than 3 months * physical or mental conditions that would not allow implementation of the exercise program or study protocol * excessive physical activity (i.e. \>150 minutes/week of moderate to intense physical activity and systematic intense strength/endurance training at least twice a week for one hour)
Where it's running
-
University Hospital Essen
Essen, Germany Recruiting
Study contacts
- Principal investigator: Miriam Götte, PD Dr. — University Hospital, Essen
- Study coordinator: Simon Basteck, M.Sc.
- Email: simon.basteck@uk-essen.de
- Phone: +49 201 723 3324
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.