INTERVAL: Ipilimumab and Nivolumab Combination Therapy: A Study of a Supervised or Semi-Supervised Exercise InteRVention or Usual Care With Functional Capacity and Quality of Life Evaluations in Subjects With Advanced or Metastatic RenAL Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Change in Cardiopulmonary function
研究概览
简要总结
This study aims to report the effects of immediate or delayed exercise training on patients with advanced or metastatic renal cell carcinoma who are receiving nivolumab and ipilimumab.
详细描述
Exercise interventions also have been shown to improve both cancer- and treatment-related fatigue and quality of life across multiple tumor types. Thus, an exercise intervention could improve the tolerability of combination immunotherapy. Furthermore, functional capacity and/or amount of physical activity are associated with survival in several cancers. Finally, there is emerging evidence that exercise training may augment beneficial cancer-specific immune function. This study will examine parallel groups of supervised or semi-supervised exercise training or usual care in patients with mRCC treated with nivolumab and ipilimumab combination therapy. Fitness level will be evaluated by cardiopulmonary exercise testing (CPET), wearable exercise tracking devices and questionnaires after 12 weeks of semi-supervised, home-based exercise.
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
- •Age ≥18 years.
- •Scheduled to receive ipilumab and nivolumab as first line of immune checkpoint inhibitor therapy for Renal Cell Carcinoma (RCC).
- •a. Patient may receive the first infusion of ipilimumab/nivolumab prior to eligibility determination
- •Subjects with brain metastases are allowed if they are asymptomatic, without edema, and not on greater than or equal to 10mg daily dose of systemic corticosteroids or receiving radiation therapy for at least 14 days prior to beginning protocol therapy.
- •Karnofsky Performance Status (KPS) of at least 70%
- •Able to walk on a treadmill per patient report.
- •Ability to understand English and the willingness to sign a written informed consent document.
排除标准
- •Major surgery (e.g. nephrectomy) less than 28 days prior to the first dose of ipilimumab/nivolumab.
- •History of cerebrovascular accident including transient ischemic attack (TIA) within the past 6 months.
- •Osseous metastatic disease with unacceptable risk of impending fracture due to study assessments, in the opinion of the investigator. Note: This criterion must be met prior to CPET.
- •Absolute contraindications to cardiopulmonary exercise testing and/or aerobic training, as determined by the attending oncologist:
- •Uncontrolled arrhythmia causing symptoms or hemodynamic compromise
- •Recurrent syncope
- •Active endocarditis
- •Acute myocarditis or pericarditis
- •Symptomatic severe aortic stenosis
- •Uncontrolled heart failure
- •Acute (within 3 months) pulmonary embolus or pulmonary infarction
- •Thrombosis of lower extremities
- •Suspected dissecting aneurysm
- •Uncontrolled asthma
- •Pulmonary edema
- •Room air desaturation at rest <85%
- •Respiratory failure
- •Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis)
- •Mental impairment leading to inability to cooperate.
- •Poorly controlled hypertension [defined as systolic blood pressure (SBP) of >150 mmHg or diastolic blood pressure (DBP) of >90 mmHg].
结局指标
主要结局
Change in Cardiopulmonary function
时间窗: Baseline, 13 weeks
Change in VO2 peak
次要结局
- Patient health outcome as measured by the EQ-5D health questionnaire(13 weeks)
- Patient-reported activity as measured by the Godin Leisure Time Exercise Questionnaire(13 weeks)
- Patient-reported activity as measured by the Stanford Brief Activity Survey(13 weeks)
- Patient-reported fatigue as measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale(13 weeks)
- Patient-reported symptoms as measured by the Functional Assessment of Cancer Therapy-Kidney Symptom Index-19 (FKSI-19)(13 weeks)
- Patient-reported activity as measured by the Incidental and Planned Activity Questionnaire(13 weeks)