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

NCT03171064 | Completed Phase 2 DMC

• 1 other identifier: Sportivumab/S-103/2017
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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

Keywords

Exercise; Cancer; Melanoma; Feasibility; PD-1 antibodies; Checkpoint inhibitors; Immune system

Outcome Measures

Primary Outcomes (1)

• Feasibility of the exercise intervention

  Participants ability to fulfill the exercise prescription (measured by % of training frequency, intensity and duration as well as type of the exercise) during immune checkpoint inhibitor treatment with a PD-1 antibody +/- ipilimumab

  During 12 week of the intervention

Secondary Outcomes (8)

• Quality of life

  During 12 week of the intervention

• Fatigue

  During 12 week of the intervention

• Sleep Quality

  During 12 week of the intervention

• Depression

  During 12 week of the intervention

• Physical Activity Behavior

  During 12 week of the intervention

Study Arms (2)

Experimental intervention arm (EX)

EXPERIMENTAL

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.

Behavioral: Resistance and Endurance Exercise

Wait list - control group (UC)

NO INTERVENTION

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

Interventions

Resistance and Endurance Exercise BEHAVIORAL

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

Experimental intervention arm (EX)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital Heidelberg: lead
• Department of Dermatology, Heidelberg University Hospital: collaborator

Study Sites (1)

Heidelberg University Clinic

Heidelberg, 69120, Germany

Location

MeSH Terms

Conditions

Motor Activity; Melanoma; Neoplasms

Condition Hierarchy (Ancestors)

Behavior; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Joachim Wiskemann

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: May 31, 2017
• Study Start: September 5, 2017
• Primary Completion: July 30, 2022
• Study Completion: December 1, 2022
• Last Updated: May 11, 2023

Record last verified: 2023-05

Locations

DE (1)