Reducing Symptom Burden Through Physical Exercise in Melanoma Patients (NCT06985056) | Clinical Trial Compass
RecruitingNot Applicable
Reducing Symptom Burden Through Physical Exercise in Melanoma Patients
Germany86 participantsStarted 2025-08-18
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Fatigue
Timeframe: From baseline assessment to the end of treatment at 12 weeks