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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
86
60 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
University Hospital Essen
Essen, Germany
RECRUITINGFatigue
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 weeks
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 weeks
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 weeks
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 weeks
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 weeks
Cardiopulmonary fitness
Cardiopulmonary fitness will be measured by assessing maximal aerobic capacity (VO2peak) via a cycling test with a protocol starting at 20 watts and increasing by 10 watts every minute until the patient reaches volitional exhaustion. To control for test validity, gas exchange will be measured using a breath-by-breath gas analysis system which will be calibrated according to the manufacturer's instructions before each test. Patients' safety will be monitored. Blood pressure will be measured prior, during and after testing. The criteria for exhaustion will be fulfilled if two out of five of the following criteria are valid: (1) Borg scale \> 16; (2) peak heart rate ± 10% of age-appropriate reference value; (3) oxygen saturation \<88%; (4) patient is not able to maintain 60rpm and/or (5) respiratory exchange ratio (RER) \> 1.1. Exercise will be terminated prematurely in the case of severe dyspnea or excessive blood pressure increase (≥250 mmHg systolic and/or ≥110 mmHg diastolic).
Time frame: From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks
Cognitive Performance
The Montreal Cognitive Assessment (MoCA, version 8.1, 8.2 and 8.3) is a validated, highly sensitive tool for early detection of mild cognitive impairment. It generates a total score and six domain-specified index scores: (1) Memory, (2) Executive Functioning, (3) Attention, (4) Language, (5) Visuospatial, (6) Orientation. Three different versions are used across three different measurement timepoints to avoid practice-related improvements in test scores.
Time frame: From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks
Body composition
Body composition will be assessed via bioelectrical impedance analysis (BIA). Body composition analysis includes (1) fat mass (FM); (2) fat-free mass (FFM); (3) body cell mass (BCM); (4) relative amount of external cell water (ECW%); (5) total body water (TBW); (6) intra cellular water (ICW); (7) appendicular skeletal muscle mass (ASMM) and (8) appendicular skeletal muscle mass index (ASMI). It also includes measurement of patients' weight and height, and the corresponding BMI.
Time frame: From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks
Weight
Weight will be assessed in kilograms.
Time frame: From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks
Height
Height will be assessed in meters.
Time frame: From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks
BMI
Weight and height will be combined to report BMI in kg/m².
Time frame: From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks
Blood pressure at rest
Assessment of blood pressure (diastolic and systolic) at rest will be conducted prior to exercise testing
Time frame: From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks
Resting heart rate
Assessment of resting heart rate will be conducted prior to exercise testing.
Time frame: From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks
Side effects/ symptoms
Evaluation of side effects or symptoms will be done via patient reported outcomes using Common Terminology Criteria for Adverse Events (PRO- CTCAE). Therefore, a standardized questionnaire containing 10 items covering most common therapy related symptoms such as (1) nausea; (2) vomiting; (3) diarrhea; (4) shortness of breath; (5) cough; (6) rash; (7) itching; (8) joint pain; (9) muscle pain; (10) decreased libido will be completed.
Time frame: From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks
Response to therapy
Blood samples will be collected at all assessment time points in the clinic. Response will be assessed by determining the common melanoma tumor markers S100 and lactate dehydrogenase (LDH).
Time frame: From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks
Blood parameters
Blood samples will be collected at all assessment time points in the clinic. Analysis of blood parameters will be conducted after the last patients' study completion to avoid batch effect in blood analysis. The following blood parameters will be analyzed: (1) metabolites (glucose, lactate, triglycerides, pyruvate, glycogen, alanine, PEP, citrate, succinate, fumarate, malate); (2) interleukins (IL-2, IL-6, IL-8, IL-10, IL-12, IL-15, IL-17, IL-23); (3) differential blood count (lymphocytes, haemoglobin levels)
Time frame: From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks
Adherence
Evaluation of patients' ability to fulfill the exercise prescription through assessment of absolute and relative numbers of completed versus planned exercise sessions.
Time frame: During the intervention phase
Assessment of Safety
Documentation of adverse events (AEs or SAEs)
Time frame: During the intervention phase
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