Evaluating the Effects of Low-moderate Intensity Pedaling During Immunotherapy Administration on Immune Biomarkers and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Feasibility of Pedaling Concurrent to Immunotherapy Infusions
研究概览
简要总结
The purpose of this study is to determine the feasibility pedaling using an under-the desk bike during immunotherapy infusions. Also, the study hopes to evaluate how pedaling impacts quality of life and treatment response biomarkers. Lastly, the study will evaluate the relationships between treatment response and muscle mass which is evaluated with computerized tomography (CT) scans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Minimum age of 18
- •Renal Cell Carcinoma, cutaneous malignancies (Melanoma, Merkel Cell Carcinoma or Squamous Cell CA) or bladder cancer.
- •Planned intravenous immunotherapy treatment (Pembrolizumab, Nivolumab, or combinations as clinically indicated by standards of care).
- •ECOG Performance Status of Grade 0-2
- •No uncontrolled cardiac disease
排除标准
- •ECOG Performance Status of Grade 3-5
- •Severe cardiac history or comorbidities (i.e. heart failure, clinically significant aortic stenosis, history of cardiac arrest, have a cardiac defibrillator, uncontrolled angina, uncontrolled arrhythmias, major heart surgery, stroke, or pulmonary embolus).
- •Chest pain or severe shortness of breath at rest or with physical activity.
- •Orthopedic impediments to exercise (i.e. joint immobility or lower extremity lymphedema).
- •Limitations to sustained exercise (i.e. bone metastases in the femur neck).
- •Severe arthritis (i.e. osteoarthritis or rheumatoid arthritis).
- •Patients will be excluded from study if their immunotherapy treatment requires the use of sedating antihistamines prior to treatment.
研究组 & 干预措施
Pedaling Group
During their 30 minute immunotherapy infusions, participants will pedal using a stationary cycle ergometer. Participants will be allowed to determine their pedaling intensity and cadence, however, will be encouraged to reach the established goal intensity level. A research personnel will monitor the patient's heart rate, blood pressure, and RPE at baseline and every 10 minutes throughout the pedaling session. Participants will also have treatment response biomarkers gathered at baseline and before and within 10 minutes of completing their first and fourth immunotherapy infusions. Lastly, participants will complete both a physical activity questionnaire and a quality of life questionnaire at baseline and following their fourth treatment.
干预措施: Pedaling Group (Behavioral)
结局指标
主要结局
Feasibility of Pedaling Concurrent to Immunotherapy Infusions
时间窗: 12 weeks
The number of completed pedaling sessions as well as the ability of patients to meet goal pedaling intensities will be evaluated.
次要结局
- Quality of life scores(12 weeks)
- Treatment response biomarkers(12 weeks)
- CT-derived sarcopenia rates(12 weeks)