PD-1 AntibodiesPhase 2SportivumabNCT03171064
Exercise as a Supportive Measure for Patients Undergoing Checkpoint-inhibitor Treatment
A Phase 2 study testing Resistance and Endurance Exercise in people with PD-1 Antibodies and Exercise, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PD-1 Antibodies, Exercise, Melanoma
- What is being tested?
- Resistance and Endurance Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteGermany
- Study dates
- 5 Sep 2017to 1 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients at age ≥ 18 years
- Diagnosed with melanoma stage (independent of stage)
- Assigned to receive an immunotherapeutic regimen (PD-1 antibody +/- Ipilimumab)
- Sufficient German language skills
- Willing to train at the exercise facilities twice per week and to take part in the scheduled testing at the National Center for Tumor Diseases
- Signed informed consent
Who cannot join
- Any physical or mental conditions that would hamper the performance of the training programs or the completion of the study procedures
- Engaging in systematic intense exercise training (at least 1h twice per week)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sportivumab - Feasibility of Exercise as a Supportive Measure for Patients Undergoing Checkpoint-inhibitor Treatment
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.
- Conditions
- PD-1 Antibodies, Exercise, Melanoma
- Being tested
- Resistance and Endurance Exercise
- Keywords
- Exercise, Cancer, Melanoma, Feasibility, PD-1 antibodies, Checkpoint inhibitors, Immune system
- Medical subject headings
- Motor Activity, Melanoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance and Endurance ExerciseBehavioural
Machine-based, 2x/week endurance and resistance training for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental intervention arm (EX) | Experimental | 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. Receives: Behavioral: Resistance and Endurance Exercise |
| Wait list - control group (UC) | No intervention | Wait list control group will receive usual care. After primary endpoint assessment, UC patients will be offered to participate in the exercise interventions program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During 12 week of the intervention
Secondary outcomes (8)
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.
Measured: 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).
Measured: 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).
Measured: During 12 week of the intervention
Depression
Depressive symptoms are assessed with the 20-item Center for Epidemiological Studies Depression Scale (CES-D).
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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.
Measured: During 12 week of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start5 Sep 2017
- Primary completion30 Jul 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PD-1 AntibodiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joachim Wiskemann, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171064
- Sponsor's protocol ID
- Sportivumab/S-103/2017
- Acronym
- Sportivumab
- Status last verified
- May 2023
- First submitted
- 24 May 2017
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Maybe pooling data with a comparable project in the united states
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sportivumab - Feasibility of Exercise as a Supportive Measure for Patients Undergoing Checkpoint-inhibitor Treatment
- ClinicalTrials.gov ID
- NCT03171064
- Acronym / sponsor ID
- Sportivumab / Sportivumab/S-103/2017
- Conditions
- PD-1 Antibodies, Exercise, Melanoma
- Keywords
- Exercise, Cancer, Melanoma, Feasibility, PD-1 antibodies, Checkpoint inhibitors, Immune system
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 31 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental intervention arm (EX) | Experimental | Behavioral: Resistance and Endurance ExerciseThe 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. |
| Wait list - control group (UC) | No intervention | –Wait list control group will receive usual care. After primary endpoint assessment, UC patients will be offered to participate in the exercise interventions program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients at age ≥ 18 years
- Diagnosed with melanoma stage (independent of stage)
- Assigned to receive an immunotherapeutic regimen (PD-1 antibody +/- Ipilimumab)
- Sufficient German language skills
- Willing to train at the exercise facilities twice per week and to take part in the scheduled testing at the National Center for Tumor Diseases
Key exclusion criteria (2 listed)
- Any physical or mental conditions that would hamper the performance of the training programs or the completion of the study procedures
- Engaging in systematic intense exercise training (at least 1h twice per week)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance and Endurance ExerciseMachine-based, 2x/week endurance and resistance training for 12 weeks | Behavioural | Experimental intervention arm (EX) |
Primary outcome
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
8 secondary outcomes
Quality of life
Time frame: During 12 week of the intervention
Fatigue
Time frame: During 12 week of the intervention
Sleep Quality
Time frame: During 12 week of the intervention
Depression
Time frame: During 12 week of the intervention
Physical Activity Behavior
Time frame: During 12 week of the intervention
Cardiopulmonary Fitness
Time frame: During 12 week of the intervention
Muscle strength
Time frame: During 12 week of the intervention
Pain
Time frame: During 12 week of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Individual participant dataSharing planned: Undecided. Maybe pooling data with a comparable project in the united states
Related trials for PD-1 Antibodies
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Not yet recruitingPhase 2
Sacituzumab Tirumotecan Plus Toripalimab for Advanced Penile Cancer After Platinum Chemotherapy
Penile Squamous Cell Carcinoma (PSCC), Advanced Penile Cancer
Not yet recruitingPhase 2
Becotatug Vedotin Plus Gemcitabine and a PD-1 Inhibitor in Recurrent or Metastatic Nasopharyngeal Carcinoma
Nasopharyngeal Carcinoma (NPC)
RecruitingPhase 1/2
A Study to Investigate ALE.P02 as a Monotherapy or in Combination With Pembrolizumab in Adult Patients With Selected CLDN1+ Solid Tumors
Squamous Non-small-cell Lung Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 3
Efficacy and Safety of AK104 Combined With Chemotherapy for Neoadjuvant Treatment of Advanced Ovarian Cancer
Advanced Ovarian Cancer, AK104(PD-1/CTLA-4 Bispecial Antibody)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Resistance and Endurance Exercise in people with PD-1 Antibodies and Exercise, run by University Hospital Heidelberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the exercise intervention (time frame: During 12 week of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.