Exercise as a Supportive Measure for Patients Undergoing Checkpoint-inhibitor Treatment (Sportivumab)
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|ClinicalTrials.gov Identifier: NCT03171064|
Recruitment Status : Recruiting
First Posted : May 31, 2017
Last Update Posted : March 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|PD-1 Antibodies Exercise Melanoma||Behavioral: Resistance and Endurance Exercise||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Sportivumab - Feasibility of Exercise as a Supportive Measure for Patients Undergoing Checkpoint-inhibitor Treatment|
|Actual Study Start Date :||September 5, 2017|
|Estimated Primary Completion Date :||November 30, 2020|
|Estimated Study Completion Date :||March 1, 2021|
Experimental: Experimental intervention arm (EX)
The supervised progressive endurance and resistance exercise program will be undertaken twice weekly in small groups and will be guided by an exercise physiotherapist over 12 weeks. All sessions will start with a warm-up passing over to the endurance training part and finish with a cool-down and will take approximately 60 minutes. The moderate-to-high-intensity endurance training will be performed at the beginning of each training session on a cycle ergometer for 20 min at 75 to 80 % of peak heart rate obtained from the baseline cardiorespiratory exercise test. This training intensity is within the range of intensities recommended by the American College of Sports Medicine (ACSM) exercise guidelines for cancer survivors. The moderate-to-high-intensity progressive resistance training regime (12 repetition maxima - 3 sets for each exercise) will include 6 exercises that target major upper and lower body muscle groups.
Behavioral: Resistance and Endurance Exercise
Machine-based, 2x/week endurance and resistance training for 12 weeks
No Intervention: Wait list - control group (UC)
Wait list control group will receive usual care. After primary endpoint assessment, UC patients will be offered to participate in the exercise interventions program.
- Feasibility of the exercise intervention [ Time Frame: During 12 week of the 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
- Quality of life [ Time Frame: During 12 week of the intervention ]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.
- Fatigue [ Time Frame: During 12 week of the intervention ]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).
- Sleep Quality [ Time Frame: During 12 week of the intervention ]Sleep quality and sleep problems will be assessed with the validated and frequently used Pittsburgh Sleep Quality Index (PSQI).
- Depression [ Time Frame: During 12 week of the intervention ]Depressive symptoms are assessed with the 20-item Center for Epidemiological Studies Depression Scale (CES-D).
- Physical Activity Behavior [ Time Frame: During 12 week of the intervention ]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.
- Cardiopulmonary Fitness [ Time Frame: During 12 week of the intervention ]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).
- Muscle strength [ Time Frame: During 12 week of the intervention ]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)
- Pain [ Time Frame: During 12 week of the intervention ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03171064
|Contact: Joachim Wiskemann, Dr||+49 6221 email@example.com|
|Contact: Friederike Rosenberger, Dr.||+49 6221 56 firstname.lastname@example.org|