Reducing Symptom Burden Through Physical Exercise in Melanoma Patients

NCT ID: NCT06985056

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-18
• Study Completion Date: 2027-11-30

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Exercise Intervention

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.

Group Type: EXPERIMENTAL

Supervised 12-week Resistance and Endurance Exercise Program

Intervention Type: 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

Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• patients ≥ 18 years with malignant melanoma (Stage IIb - IV) receiving adjuvant immuno- or targeted therapy
• patients already on the same treatment protocol for at least 3 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universität Duisburg-Essen

OTHER

Sponsor Role: lead

Responsible Party

Miriam Götte

PD Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miriam Götte, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Essen

Locations

University Hospital Essen

Essen, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Simon Basteck, M.Sc.

Role: CONTACT

simon.basteck@uk-essen.de

+49 201 723 3324

Other Identifiers

RESPECT

Identifier Type: -

Identifier Source: org_study_id