NCT07680556 Promoting Response to IMmunotherapy by Exercise in Patients With Advanced Renal Cell Carcinoma
| NCT ID | NCT07680556 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Radboud University Medical Center |
| Condition | Oncology |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-07-22 |
| Primary Completion | 2028-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2026-07-22 with a primary completion date of 2028-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Laurien M Buffart, PhD
PRINCIPAL INVESTIGATOR
Radboud University Medical Center
Frequently Asked Questions
Who can join the NCT07680556 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Oncology. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07680556 currently recruiting?
Yes, NCT07680556 is actively recruiting participants. Contact the research team at laurien.buffart@radboudumc.nl for enrollment information.
Where is the NCT07680556 trial being conducted?
This trial is being conducted at Arnhem, Netherlands, Nijmegen, Netherlands.
Who is sponsoring the NCT07680556 clinical trial?
NCT07680556 is sponsored by Radboud University Medical Center. The principal investigator is Laurien M Buffart, PhD at Radboud University Medical Center. The trial plans to enroll 30 participants.