NCT06985056Recruiting
Reducing Symptom Burden Through Physical Exercise in Melanoma Patients
Reducing Symptom Burden Through Physical Exercise in Melanoma Patients Under Immuno- or Targeted Therapy
Source: ClinicalTrials.gov · Last updated 8 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 86 (estimated)
- First submitted
- 8 May 2025
- Start date
- 18 Aug 2025
- Primary completion date
- Sept 2027
- Lead sponsor
- Universität Duisburg-Essen
- Diseases
- Melanoma
- NCT number
- NCT06985056
What you commit to
- Study type: Interventional
- Planned participants: 86
- From 18 Aug 2025 to the primary completion date, Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- severe neurological or cardiac impairment according to ACSM criteria
- confirmation of respiratory insufficiency by the attending physician
- physical or mental conditions that would not allow implementation of the exercise program or study protocol
Other
- 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
- life expectancy less than 3 months
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Essen Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.