Clinical trial NCT06985056: Reducing Symptom Burden Through Physical Exercise in Melanoma Patients
Official title: Reducing Symptom Burden Through Physical Exercise in Melanoma Patients Under Immuno- or Targeted Therapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Malignant Melanoma
Keywords: Exercise
Fatigue
Physical Activity
Checkpoint Inhibitors
BRAF/MEK Inhibitors
Melanoma
Quality of Life
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 criteria: Inclusion Criteria:

* patients ≥ 18 years with malignant melanoma (Stage IIb - IV) receiving adjuvant immuno- or targeted therapy
* patients already on the same treatment protocol for at least 3 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)

Primary outcomes:
measure: Fatigue
timeFrame: From baseline assessment to the end of treatment at 12 weeks
Secondary outcomes:
measure: Fatigue
timeFrame: From the end of treatment to follow-up assessment at 18 weeks
measure: Quality of life of melanoma patients
timeFrame: From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks
measure: Physical Activity Behaviour
timeFrame: From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks
measure: Strength of large muscle groups
timeFrame: From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks
measure: Cardiopulmonary fitness
timeFrame: From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks
measure: Cognitive Performance
timeFrame: From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks
measure: Body composition
timeFrame: From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks
measure: Weight
timeFrame: From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks
measure: Height
timeFrame: From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks
measure: BMI
timeFrame: From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks
measure: Blood pressure at rest
timeFrame: From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks
measure: Resting heart rate
timeFrame: From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks
measure: Side effects/ symptoms
timeFrame: From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks
measure: Response to therapy
timeFrame: From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks
measure: Blood parameters
timeFrame: From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks
measure: Adherence
timeFrame: During the intervention phase
measure: Assessment of Safety
timeFrame: During the intervention phase
Other outcomes:
Locations:
city: Essen
country: Germany
facility: University Hospital Essen
Study officials:
affiliation: University Hospital, Essen
name: Miriam Götte, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References: