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PRIMER

Promoting Response to IMmunotherapy by Exercise in patients with advanced Renal cell Carcinoma - PRIMER

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON61167
Enrollment
30
Registered
2026-02-03
Start date
2026-07-22
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced renal cell carcinoma Kidney cancer

Interventions

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participants in the intervention group will follow a 12-week training program consisting of:Two supervised aerobic training sessions of 60 minutes per week, provided by an oncology-trained physiothera

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

MeasureTime 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

MeasureTime 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

Public ContactL M Buffart

Radboud Universitair Medisch Centrum

laurien.buffart@radboudumc.nl0243667310

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 25, 2026