Reducing Symptom Burden Through Physical Exercise in Melanoma Patients
ConditionMalignant Melanoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversität Duisburg-Essen
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Supervised 12-week Resistance and Endurance Exercise Program
Behavioral60 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
Treatment groups
86 Participants
are divided into 2 treatment groupsGroup A: Exercise InterventionExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Fatigue
Fatigue will be assessed with the validated 40-item Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F, version 4). It includes four multi-item functional scales (physical, social, emotional and functional well-being) and a multi-item symptom scale (fatigue).
Time frame
From baseline assessment to the end of treatment at 12 weeksSecondary outcomes
1
Fatigue
Fatigue will be assessed with the validated 40-item Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F, version 4). It includes four multi-item functional scales (physical, social, emotional and functional well-being) and a multi-item symptom scale (fatigue).
Time frame
From the end of treatment to follow-up assessment at 18 weeks2
Quality of life of melanoma patients
Quality of Life (QoL) will be assessed with the validated 51-item Functional Assessment of Cancer Therapy - Melanoma (FACT-M, version 3). It includes four multi-item functional scales (physical, social, emotional and functional well-being) and a multi-item disease-specific subscale.
Time frame
From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks3
Physical Activity Behaviour
Physical Activity (PA) behaviour in the domains of activity at work, during leisure time, and exercise activity will be assessed via a standardized and validated questionnaire, the Physical activity and Sports activity Questionnaire (Bewegungs- und SportAktivitätsfragebogen (BSA, version 3.0)).
Time frame
From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks4
Strength of large muscle groups
Muscle strength will be assessed via 5-repetition-maximum strength test for large muscle groups. The protocol includes leg press, bench press, and lat pulldown
Time frame
From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeksSponsors and contacts
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Source ClinicalTrials.gov