Metastatic Renal Cell Carcinoma
Conditions
Keywords
metastatic renal cell carcinoma, ipilimumab, nivolumab, exercise
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALExercise
Patients will be asked to complete 3 x 30 minute exercise sessions each week.
Sponsors
Bristol-Myers Squibb
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Patients will be assigned to one of three cohorts: Supervised exercise, semi-supervised exercise or usual care.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years. 2. 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 3. 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. 4. Karnofsky Performance Status (KPS) of at least 70% 5. Able to walk on a treadmill per patient report. 6. Ability to understand English and the willingness to sign a written informed consent document.
Exclusion criteria
1. Major surgery (e.g. nephrectomy) less than 28 days prior to the first dose of ipilimumab/nivolumab. 2. History of cerebrovascular accident including transient ischemic attack (TIA) within the past 6 months. 3. 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. 4. 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 \[defined as systolic blood pressure (SBP) of \>150 mmHg or diastolic blood pressure (DBP) of \>90 mmHg\].
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cardiopulmonary function | Baseline, 13 weeks | Change in VO2 peak |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported activity as measured by the Godin Leisure Time Exercise Questionnaire | 13 weeks | The Godin Leisure is a patient-reported outcome tool to measure activity |
| Patient-reported symptoms as measured by the Functional Assessment of Cancer Therapy-Kidney Symptom Index-19 (FKSI-19) | 13 weeks | The FKSI-19 is a patient-reported outcome tool to measure symptoms of Cancer |
| Patient-reported fatigue as measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale | 13 weeks | The FACIT-F measures severity and impact of fatigue on functioning and health-related quality of life experienced in past seven days using 40 statements that patients are asked to rate as 0-4 with 0 being Not at all and 4 being Very much. |
| Patient-reported activity as measured by the Stanford Brief Activity Survey | 13 weeks | The Stanford Brief Activity Survey is a patient-reported outcome tool to measure activity |
| Patient-reported activity as measured by the Incidental and Planned Activity Questionnaire | 13 weeks | The Incidental and Planned Activity Questionnaire is a patient-reported outcome tool to measure activity |
| Patient health outcome as measured by the EQ-5D health questionnaire | 13 weeks | The EQ-5d is a patient-reported outcome tool to measure health |
Countries
United States
Outcome results
None listed