advanced renal cell carcinoma Kidney cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Age =18 years.Advanced RCC with indication for standard-of-care dual ICI treatment.Scheduled for first-line treatment with nivolumab plus ipilimumab.Able and willing to give written informed consent.
Exclusion criteria
Exclusion criteria: Life expectancy <6 months. Unable to perform basic activities of daily living such as walking.Presence of cognitive impairment or severe emotional instability (e.g. schizophrenia, Alzheimer’s disease, alcohol addiction), at the discretion of the investigator.Presence of other disabling comorbidities that may interfere with the ability to perform physical exercise (e.g., heart failure, chronic obstructive pulmonary disease (COPD, GOLD stage 3 or 4), orthopaedic conditions, or neurological disorders such as hernia, paresis, amputation or active rheumatoid arthritis), at the discretion of the investigator.Current participation in structured vigorous aerobic and/or resistance exercise = 2 times per week at a level comparable to the intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the primary outcome measure is feasibility, which includes:The number of patients willing to participateThe number of patients who complete the studyAdherence to and compliance with the study protocolThe occurrence of exercise-related adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcomes of this study are:To look at the effects of exercise on the immune system, including T cells, natural killer cells and cytokines.Study changes in gut bacteriaphysical fitnesspatient reported outcomes such as fatigue, quality of life, emotional distress, sleep and diet.clinical outcomes such as how well patients respond to treatment, how long the disease stays under control and overall survivalChanges in immune function and gut bacteria and how these are related to clinical outcomes | — |
Countries
Netherlands
Contacts
Radboud Universitair Medisch Centrum