Promoting Response to IMmunotherapy by Exercise in Patients With Advanced Renal Cell Carcinoma
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
The primary aim of this study is to evaluate the feasibility of a supervised high intensity interval training (HIIT) program during first-line dual immune checkpoint inhibitor (ICI) therapy (nivolumab plus ipilimumab) in patients with advanced renal cell carcinoma (RCC). The second aim is to generate preliminary data on the effects of exercise on the immune cell phenotype and function, gut microbiota composition, physical fitness, patient-reported outcomes and clinical outcomes. This is a two-arm randomized controlled pilot trial in which 30 patients with advanced RCC scheduled to receive first-line nivolumab plus ipilimumab will be randomized in 1:1 ratio to an exercise intervention group or usual care group. The exercise intervention consists of two 60-minute supervised HIIT sessions per week, delivered by oncology-trained physiotherapists and one additional home-based moderate-intensity aerobic exercise sessions per week. The intervention starts with the first cycle of immunotherapy and continues for four treatment cycles. Participants in both groups will receive usual care and general exercise guidelines. Measurements include blood and stool sampling for microbiome and immune parameters analysis, physical fitness assessments, physical fitness monitoring, body composition measurements, and patient-reported outcomes related to quality of life, fatigue, depression, sleep and diet.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18 lat lub więcej
- •Rozpoznany zaawansowany rak nerki wymagający standardowego leczenia dwoma lekami immunologicznymi
- •Zdolność do złożenia pisemnej zgody na uczestnictwo w badaniu
✗ Disqualifies
- •Spodziewana długość życia poniżej 6 miesięcy
- •Niemożność wykonywania codziennych czynności, takich jak chodzenie
- •Poważne zaburzenia psychiczne, demencja lub uzależnienia
- •Poważne choroby serca, płuc lub zaburzenia neurologiczne, które uniemożliwiają ćwiczenia
- •Już regularny intensywny trening fizyczny co najmniej 2 razy w tygodniu
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 24, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (2)
Rijnstate
Arnhem, Netherlands
Radboudumc
Nijmegen, Netherlands
Trial contact
Laurien Buffart, PhD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/26/2026.
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