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Search / Trial NCT06985056

Reducing Symptom Burden Through Physical Exercise in Melanoma Patients

Launched by UNIVERSITÄT DUISBURG-ESSEN · May 19, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Exercise Fatigue Physical Activity Checkpoint Inhibitors Braf/Mek Inhibitors Melanoma Quality Of Life

ClinConnect Summary

This clinical trial is studying whether regular exercise can help reduce fatigue and improve the quality of life for adult patients with advanced melanoma (stage IIb-IV) who are undergoing specific cancer treatments called immunotherapy or targeted therapy. The trial will compare patients who participate in a 12-week supervised exercise program to those who do not receive any structured exercise. Participants in the exercise group will attend online training sessions twice a week, along with some in-person sessions at the clinic, and they will also do a short exercise routine on their own each week.

To be eligible for this trial, patients must be 18 years or older, have a confirmed diagnosis of malignant melanoma, and have been on their current treatment for at least three months. They should also be able to understand German and provide medical clearance for exercise. Those who have certain health issues, such as severe heart or lung problems, or who are overly active already may not qualify. Throughout the study, participants will have assessments to track their progress and health outcomes, helping researchers understand how exercise impacts their overall well-being and treatment experience.

Gender

ALL

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)

About Universität Duisburg Essen

The Universität Duisburg-Essen is a prominent academic institution in Germany, renowned for its commitment to research and innovation in various fields, including medicine and health sciences. As a clinical trial sponsor, the university leverages its interdisciplinary expertise and state-of-the-art facilities to advance clinical research initiatives. With a focus on improving patient outcomes, the university actively collaborates with healthcare professionals, industry partners, and regulatory bodies to conduct rigorous clinical trials that adhere to the highest ethical and scientific standards. Through its dedication to enhancing clinical knowledge and fostering new therapeutic approaches, Universität Duisburg-Essen plays a pivotal role in the evolution of modern healthcare.

Locations

Essen, , Germany

Patients applied

0 patients applied

Trial Officials

Miriam Götte, PD Dr.

Principal Investigator

University Hospital, Essen

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported