RecruitingNot ApplicableNCT07680556

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

Sponsor

Radboud University Medical Center

Enrollment

30 participants

Start Date

Jul 22, 2026

Study Type

INTERVENTIONAL

Conditions

Oncology

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called HIIT for people with oncology. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALHIIT

The intervention group will be offered a supervised exercise program consisting of two 60-minute sessions per week, including continuous aerobic exercise and HIIT. Sessions will be supervised by physiotherapists specialized in oncology, and the training load will be tailored to a patient's individual fitness levels throughout the intervention. Following a short warm-up, participants will perform repeated high-intensity cycling intervals targeting 85-95% of their estimated peak heart rate corresponding to a Borg Rating of Perceived Exertion (RPE) 16-18), interspersed with periods of active recovery at light intensity. The HIIT component will be followed by moderate-intensity aerobic exercise at approximately 70% of the estimated heart rate (Borg RPE 13-14), and a cool-down period. In addition, participants will be asked to be physically active for at least 30 minutes at moderate intensity, in accordance with the American College of Sports Medicine (ACSM) guidelines.