NCT07680556Recruiting
Promoting Response to IMmunotherapy by Exercise in Patients With Advanced Renal Cell Carcinoma
Source: ClinicalTrials.gov · Last updated 28 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 17 Jun 2026
- Start date
- Jul 2026
- Primary completion date
- Jul 2028
- Lead sponsor
- Radboud University Medical Center
- Diseases
- Kidney cancer
- NCT number
- NCT07680556
What you commit to
- Study type: Interventional
- Planned participants: 30
- From Jul 2026 to the primary completion date, Jul 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Life expectancy \<6 months.
- Unable to perform basic activities of daily living such as walking.
- Current participation in structured vigorous aerobic and/or resistance exercise ≥ 2 times per week at a level comparable to the intervention
Who the study is looking for
- Age ≥18 years.
- Diagnosed with advanced RCC with indication for standard-of-care dual ICI treatment.
- Able and willing to give written informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rijnstate Coordinator of this site? Confirm its status | Arnhem | Netherlands | Recruiting |
| Radboudumc Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.