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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
2
Patients will be asked to complete 3 x 30 minute exercise sessions each week.
Duke University Medical Center
Durham, North Carolina, United States
Change in Cardiopulmonary function
Change in VO2 peak
Time frame: Baseline, 13 weeks
Patient-reported fatigue as measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale
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".
Time frame: 13 weeks
Patient-reported activity as measured by the Godin Leisure Time Exercise Questionnaire
The Godin Leisure is a patient-reported outcome tool to measure activity
Time frame: 13 weeks
Patient-reported symptoms as measured by the Functional Assessment of Cancer Therapy-Kidney Symptom Index-19 (FKSI-19)
The FKSI-19 is a patient-reported outcome tool to measure symptoms of Cancer
Time frame: 13 weeks
Patient health outcome as measured by the EQ-5D health questionnaire
The EQ-5d is a patient-reported outcome tool to measure health
Time frame: 13 weeks
Patient-reported activity as measured by the Stanford Brief Activity Survey
The Stanford Brief Activity Survey is a patient-reported outcome tool to measure activity
Time frame: 13 weeks
Patient-reported activity as measured by the Incidental and Planned Activity Questionnaire
The Incidental and Planned Activity Questionnaire is a patient-reported outcome tool to measure activity
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Time frame: 13 weeks