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Promoting Response to IMmunotherapy by Exercise in Patients With Advanced Renal Cell Carcinoma

RecruitingNAAges 18 Years - anyAllRadboud University Medical Center
NCT07680556 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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-intens

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥18 years. * Diagnosed with advanced RCC with indication for standard-of-care dual ICI treatment. * Able and willing to give written informed consent. 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
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What it tests

  • HIIT
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Where

2 sites
Rijnstate
Arnhem, Netherlands
Radboudumc
Nijmegen, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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