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

NCT ID: NCT03171064

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-05
• Study Completion Date: 2022-12-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Experimental intervention arm (EX)

The supervised progressive endurance and resistance exercise program will be undertaken twice weekly in small groups and will be guided by an exercise physiotherapist over 12 weeks. All sessions will start with a warm-up passing over to the endurance training part and finish 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 on a cycle ergometer for 20 min at 75 to 80 % of peak heart rate obtained from the baseline cardiorespiratory exercise test. This training intensity is within the range of intensities recommended by the American College of Sports Medicine (ACSM) exercise guidelines for cancer survivors. The moderate-to-high-intensity progressive resistance training regime (12 repetition maxima - 3 sets for each exercise) will include 6 exercises that target major upper and lower body muscle groups.

Group Type: EXPERIMENTAL

Resistance and Endurance Exercise

Intervention Type: BEHAVIORAL

Machine-based, 2x/week endurance and resistance training for 12 weeks

Wait list - control group (UC)

Wait list control group will receive usual care. After primary endpoint assessment, UC patients will be offered to participate in the exercise interventions program.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Resistance and Endurance Exercise

Machine-based, 2x/week endurance and resistance training for 12 weeks

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Department of Dermatology, Heidelberg University Hospital

UNKNOWN

Sponsor Role: collaborator

University Hospital Heidelberg

OTHER

Sponsor Role: lead

Responsible Party

Joachim Wiskemann

Dr. Joachim Wiskemann

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Heidelberg University Clinic

Heidelberg, , Germany

Countries

Germany

Other Identifiers

Sportivumab/S-103/2017

Identifier Type: -

Identifier Source: org_study_id