Sportivumab - Feasibility of Exercise as a Supportive Measure for Patients Undergoing Checkpoint-inhibitor Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Feasibility of the exercise intervention
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Feasibility of the exercise intervention
时间窗: During 12 week of the 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
次要结局
- Quality of life(During 12 week of the intervention)
- Depression(During 12 week of the intervention)
- Fatigue(During 12 week of the intervention)
- Muscle strength(During 12 week of the intervention)
- Pain(During 12 week of the intervention)
- Physical Activity Behavior(During 12 week of the intervention)
- Cardiopulmonary Fitness(During 12 week of the intervention)
- Sleep Quality(During 12 week of the intervention)
研究者
Joachim Wiskemann
Dr. Joachim Wiskemann
University Hospital Heidelberg