NCT03171064

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: University Hospital Heidelberg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• PD-1 Antibodies
• Exercise
• Melanoma

Interventions

Type	Name	Description
BEHAVIORAL	Resistance and Endurance Exercise	Machine-based, 2x/week endurance and resistance training for 12 weeks

Timeline

• Start date: 2017-09-05
• Primary completion: 2022-07-30
• Completion: 2022-12-01
• First posted: 2017-05-31
• Last updated: 2023-05-11

Locations

1 site across 1 country: Germany