Malignant MelanomaRESPECTNCT06985056
Reducing Symptom Burden Through Physical Exercise in Melanoma Patients
A study testing Supervised 12-week Resistance and Endurance Exercise Program in people with Malignant Melanoma, run by Universität Duisburg-Essen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- Supervised 12-week Resistance and Endurance Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteGermany
- Study dates
- 18 Aug 2025to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 ≥ 18 years with malignant melanoma (Stage IIb - IV) receiving adjuvant or palliative immunotherapy or targeted therapy
- patients with ECOG level 0-2
- patients already on the same treatment protocol for at least 3 months and no more than 9 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Reducing Symptom Burden Through Physical Exercise in Melanoma Patients Under Immuno- or Targeted Therapy
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.
- Conditions
- Malignant Melanoma
- Being tested
- Supervised 12-week Resistance and Endurance Exercise Program
- Keywords
- Exercise, Fatigue, Physical Activity, Checkpoint Inhibitors, BRAF/MEK Inhibitors, Melanoma, Quality of Life
- Medical subject headings
- Melanoma, Motor Activity, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised 12-week Resistance and Endurance Exercise ProgramBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention | Experimental | The supervised progressive endurance and resistance exercise program will be conducted twice per week online in small groups and will be guided by a sports scientist over a period of 12 weeks. All sessions will start with a warm-up, transitioning to endurance training, followed by strength exercises and finishing 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 for 15 minutes in the range of the ventilatory threshold 1 (VT1), which was obtained during the baseline cardiorespiratory exercise test. The moderate-to-high-intensity progressive resistance training and bodyweight regime will include 6 exercises that target major upper and lower body muscle groups as well as trunk exercises. Resistance exercise includes free weight, resistance bands, and bodyweight workouts. Receives: Behavioral: Supervised 12-week Resistance and Endurance Exercise Program |
| Control Group | No intervention | Control group will receive usual care without an exercise program. After the final endpoint assessment, patients randomized into the control group will be offered the opportunity to participate in an exercise program conducted by the Sports and Exercise Therapy Group at WTZ Essen. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From baseline assessment to the end of treatment at 12 weeks
Secondary outcomes (17)
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).
Measured: 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.
Measured: 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)).
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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.
Measured: During the intervention phase
Assessment of Safety
Documentation of adverse events (AEs or SAEs)
Measured: During the intervention phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start18 Aug 2025
- Primary completionSep 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant MelanomaStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miriam Götte, Universität Duisburg-Essen
- Investigators
- Miriam Götte, PD Dr., Principal investigator, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985056
- Sponsor's protocol ID
- RESPECT
- Acronym
- RESPECT
- Status last verified
- Mar 2026
- First submitted
- 8 May 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Symptom Burden Through Physical Exercise in Melanoma Patients Under Immuno- or Targeted Therapy
- ClinicalTrials.gov ID
- NCT06985056
- Acronym / sponsor ID
- RESPECT / RESPECT
- Conditions
- Malignant Melanoma
- Keywords
- Exercise, Fatigue, Physical Activity, Checkpoint Inhibitors, BRAF/MEK Inhibitors, Melanoma, Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 22 May 2025 (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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Experimental | Behavioral: Supervised 12-week Resistance and Endurance Exercise ProgramThe supervised progressive endurance and resistance exercise program will be conducted twice per week online in small groups and will be guided by a sports scientist over a period of 12 weeks. All sessions will start with a warm-up, transitioning to endurance training, followed by strength exercises and finishing 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 for 15 minutes in the range of the ventilatory threshold 1 (VT1), which was obtained during the baseline cardiorespiratory exercise test. The moderate-to-high-intensity progressive resistance training and bodyweight regime will include 6 exercises that target major upper and lower body muscle groups as well as trunk exercises. Resistance exercise includes free weight, resistance bands, and bodyweight workouts. |
| Control Group | No intervention | –Control group will receive usual care without an exercise program. After the final endpoint assessment, patients randomized into the control group will be offered the opportunity to participate in an exercise program conducted by the Sports and Exercise Therapy Group at WTZ Essen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- patients ≥ 18 years with malignant melanoma (Stage IIb - IV) receiving adjuvant or palliative immunotherapy or targeted therapy
- patients with ECOG level 0-2
- patients already on the same treatment protocol for at least 3 months and no more than 9 months
- sufficient knowledge of German
- completed and signed written consent form and completed medical history form
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Supervised 12-week Resistance and Endurance Exercise Program60 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 | Behavioural | Exercise Intervention |
Primary outcome
Fatigue
Time frame: From baseline assessment to the end of treatment at 12 weeks
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).
17 secondary outcomes
Fatigue
Time frame: From the end of treatment to follow-up assessment at 18 weeks
Quality of life of melanoma patients
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Time frame: During the intervention phase
Assessment of Safety
Time frame: During the intervention phase
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Miriam Götte, PD Dr. principal investigator
University Hospital, Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised 12-week Resistance and Endurance Exercise Program in people with Malignant Melanoma, run by Universität Duisburg-Essen 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 8 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 8 Jul 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simon Basteck, M.Sc. (+49 201 723 3324, simon.basteck@uk-essen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: From baseline assessment to the end of treatment at 12 weeks). 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 8 Jul 2026.