Reducing Symptom Burden Through Physical Exercise in Melanoma Patients

Official title

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

Overview

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.

Interventions

• Behavioral Supervised 12-week Resistance and Endurance Exercise Program
  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 outcome measures

• Fatigue [Time frame: From baseline assessment to the end of treatment at 12 weeks]

Secondary outcome measures (12)

• 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Germany · 1 center

• University Hospital Essen — Essen

Identifiers

NCT: NCT06985056 · RESPECT

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗