Checkpoint inhibitors like the PD-1 antibodies Pembrolizumab and Nivolumab represent standard of care for patients with metastasized melanoma. Numerous high quality studies demonstrate that endurance and resistance training in cancer patients is safe and elicits beneficial effects. However, there is no systematic experience with regard to exercise interventions in patients undergoing checkpoint inhibitor treatment. Therefore, the Sportivumab Study aimed to investigate safety, feasibility and effectivity of a 12 week combined resistance and endurance exercise intervention program during checkpoint inhibitor treatment. It is planned to enroll 40 patients. Participants will be randomized into an experimental and a wait-list control group (20 per group). The wait-list control group will receive the exercise intervention program after week 13 of enrollment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
39
Machine-based, 2x/week endurance and resistance training for 12 weeks
Heidelberg University Clinic
Heidelberg, Germany
Feasibility of the exercise intervention
Participants ability to fulfill the exercise prescription (measured by % of training frequency, intensity and duration as well as type of the exercise) during immune checkpoint inhibitor treatment with a PD-1 antibody +/- ipilimumab
Time frame: During 12 week of the intervention
Quality of life
Quality of life (QoL) will be assessed with the validated 30-item self-assessment questionnaire of the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30, version 3.0). It includes five multi-item functional scales (physical, role, emotional, cognitive, and social function), three multi-item symptom scales (fatigue, pain, nausea/vomiting), and six single items assessing further symptoms (dyspnea, insomnia, appetite loss, constipation, diarrhea) and financial difficulties.
Time frame: During 12 week of the intervention
Fatigue
Fatigue will be assessed with the Multidimensional Fatigue Inventory (MFI) which is a 20-item, multidimensional self-assessment questionnaire that has been validated for a German-speaking population.It covers five different dimensions of fatigue (general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue).
Time frame: During 12 week of the intervention
Sleep Quality
Sleep quality and sleep problems will be assessed with the validated and frequently used Pittsburgh Sleep Quality Index (PSQI).
Time frame: During 12 week of the intervention
Depression
Depressive symptoms are assessed with the 20-item Center for Epidemiological Studies Depression Scale (CES-D).
Time frame: During 12 week of the intervention
Physical Activity Behavior
Physical activity (PA) behavior in the domains of commuting activity, leisure time activities such as cycling, walking, and sports, household and occupational activity will be assessed via a standardized and validated questionnaire, the Short QUestionnaire to ASsess Health-enhancing PA (SQUASH) which has the advantage that it is short and easy to complete.
Time frame: During 12 week of the intervention
Cardiopulmonary Fitness
Cardiopulmonary fitness will be measured by assessing maximal aerobic capacity (VO2peak) via a maximal incremental cycling test with a quasi-ramp protocol starting at 20 watts and increasing by 10 watts every minute until 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 instructions of the manufacturer before each test. To monitor patient safety, a 12-lead electrocardiogram (ECG) will be and blood pressure will be measured prior, during and after testing. The criteria for exhaustion will be fulfilled if two out of three of the following criteria are valid: (1) Borg scale \> 16; (2) peak heart rate ± 10% of age-appropriate reference value and/or (3) respiratory exchange ratio (RER) \> 1.1. Exercise will be terminated prematurely in the case of major ECG abnormalities, severe dyspnea or excessive blood pressure increase (≥250 mmHg systolic and/or ≥110 mmHg diastolic).
Time frame: During 12 week of the intervention
Muscle strength
Isometric (in four different joint angle positions) and isokinetic (at 60° angle speed) muscle capacity is measured with the Isomed 2000® diagnostic module (isokinetic evaluation and training machine). The protocol includes testing of representative muscles groups for upper (elbow flexors/extensors) and lower extremity (knee extensors/flexors)
Time frame: During 12 week of the intervention
Pain
The Brief Pain Inventory (BPI) is a 14-item questionnaire developed for use in patients with cancer that assesses worst pain, pain severity, and pain interference over the past week, reported on a scale of 0 to 10. Worst pain is categorized as mild (score of 3 to 4), moderate (score of 5 to 7), or severe pain (score of 8 to 10). Pain severity is measured as the average of responses to questions on worst pain, average pain, least pain, and pain right now. Pain interference is the average of seven interference items, such as walking, mood, and sleep.
Time frame: During 12 week of the intervention
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