Reducing Symptom Burden Through Physical Exercise in Melanoma Patients

NCT06985056 | Recruiting

• 1 other identifier: RESPECT
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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

Keywords

Exercise; Fatigue; Physical Activity; Checkpoint Inhibitors; BRAF/MEK Inhibitors; Melanoma; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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).

  From baseline assessment to the end of treatment at 12 weeks

Secondary Outcomes (17)

• Fatigue

  From the end of treatment to follow-up assessment at 18 weeks

• Quality of life of melanoma patients

  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

  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

  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

  From baseline assessment to the end of treatment at 12 weeks, from the end of treatment to follow-up assessment at 18 weeks

Study Arms (2)

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.

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.

Interventions

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

Exercise Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universität Duisburg-Essen: lead

Study Sites (1)

University Hospital Essen

Essen, 45147, Germany

RECRUITING

MeSH Terms

Conditions

Melanoma; Motor Activity; Fatigue

Condition Hierarchy (Ancestors)

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

Study Officials

• Miriam Götte, PD Dr.

  University Hospital, Essen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon Basteck, M.Sc.

CONTACT

+49 201 723 3324; simon.basteck@uk-essen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr.

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 22, 2025
• Study Start: August 18, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)