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SPORTIVUMAB Study

Resistance and endurance training in patients with malign melanoma undergoing immune therapy

Brief description

There is strong evidence for positive effects of physical training in cancer patients undergoing chemotherapy, radiation, or hormone therapy. These effects include higher physical performance, reduced side effects like fatigue, and potentially a better prognosis.

Immune therapy is a relatively new generation of anti-cancer therapies. Over the past years, so called checkpoint inhibitors (e.g. Nivolumab, Ipilimumab) have improved therapy options for patients with metastatic malign melanoma. However, a checkpoint inhibitor therapy may have side effects. Besides immune-related side effects, which are treated with glucocorticoids, fatigue is common and difficult to treat.

Resistance and endurance training might also increase physical performance and reduce fatigue as well as side effects of the glucocorticoid therapy in patients undergoing immune therapy. However, this has not been investigated yet. Therefore, feasibility and effects of physical training in melanoma patients undergoing checkpoint inhibitor therapy are investigated in the Sportivumab study.

40 patients with metastatic malign melanoma starting a checkpoint inhibitor therapy (Nivolumab with or without Ipilimumab) will be recruited. Patients will be randomized to either a training group or a waitlist control group. In the training group, patients will undergo 12 weeks of machine based resistance and endurance training at the NCT or another training center nearby their home via the network OnkoAktiv. In the waitlist control group, patients will be monitored for 12 weeks and can start their training program afterwards.

The combined resistance and endurance training program will be individually tailored according to the patients’ health status and performance level. Experienced sports- and physiotherapists will supervise the training program.

Current status

Recruitment is open since May 2017.

Contact information

Paula Hoffmann (study management)
Tel.: +49 6221 56-35691
E-mail: paula.hoffmann(at)nct-heidelberg.de