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NCT Number: NCT06985056

Reducing Symptom Burden Through Physical Exercise in Melanoma Patients

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.

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Key information

Conditions

Malignant Melanoma Behavior Fatigue Melanoma Motor Activity Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Essen

Essen, 45147, Germany

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Supervised 12-week Resistance and Endurance Exercise Program

Behavioral

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. Fatigue

    Time frame: From the end of treatment to follow-up assessment at 18 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).

  2. 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

    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.

  3. 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

    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)).

  4. 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

    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

  5. 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

    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).

  6. 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

    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.

  7. 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

    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.

  8. 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

    Weight will be assessed in kilograms.

  9. 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

    Height will be assessed in meters.

  10. 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 and height will be combined to report BMI in kg/m².

  11. 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

    Assessment of blood pressure (diastolic and systolic) at rest will be conducted prior to exercise testing

  12. 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

    Assessment of resting heart rate will be conducted prior to exercise testing.

  13. 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

    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.

  14. 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 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).

  15. 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

    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)

  16. Adherence

    Time frame: During the intervention phase

    Evaluation of patients' ability to fulfill the exercise prescription through assessment of absolute and relative numbers of completed versus planned exercise sessions.

  17. Assessment of Safety

    Time frame: During the intervention phase

    Documentation of adverse events (AEs or SAEs)

Study contacts

Contact information is provided by the study sponsor or research team.

Simon Basteck, M.Sc.

CONTACT

[email protected]

+49 201 723 3324

Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Registry information

Official study title

Reducing Symptom Burden Through Physical Exercise in Melanoma Patients Under Immuno- or Targeted Therapy

Acronym: RESPECT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 22, 2025
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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