Exercise as a Supportive Measure for Patients Undergoing Checkpoint-inhibitor Treatment

Sportivumab - Feasibility of Exercise as a Supportive Measure for Patients Undergoing Checkpoint-inhibitor Treatment

Checkpoint inhibitors like the PD-1 antibodies Pembrolizumab and Nivolumab represent standard of care for patients with metastasized melanoma. Numerous high quality studies demonstrate that endurance and resistance training in cancer patients is safe and elicits beneficial effects. However, there is no systematic experience with regard to exercise interventions in patients undergoing checkpoint inhibitor treatment. Therefore, the Sportivumab Study aimed to investigate safety, feasibility and effectivity of a 12 week combined resistance and endurance exercise intervention program during checkpoint inhibitor treatment. It is planned to enroll 40 patients. Participants will be randomized into an experimental and a wait-list control group (20 per group). The wait-list control group will receive the exercise intervention program after week 13 of enrollment.

Inclusion Criteria:

• Patients at age ≥ 18 years
• Diagnosed with melanoma stage (independent of stage)
• Assigned to receive an immunotherapeutic regimen (PD-1 antibody +/- Ipilimumab)
• Sufficient German language skills
• Willing to train at the exercise facilities twice per week and to take part in the scheduled testing at the National Center for Tumor Diseases
• Signed informed consent

Exclusion Criteria:

• Any physical or mental conditions that would hamper the performance of the training programs or the completion of the study procedures
• Engaging in systematic intense exercise training (at least 1h twice per week)