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INTERVAL - exercise in renal cell carcinoma - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out whether treatment with ipilimumab and nivolumab changes the physical fitness level and heart and vascular function in patients with advanced kidney cancer.

We are also want to find out whether exercise testing can help physical fitness and quality of life in these patients.

What is the Condition Being Studied?

Kidney Cancer (Renal Cell Carcinoma)

Who Can Participate in the Study?

Adult patients with kidney cancer who:
- Plan to get ipilimumab with nivolumab to treat kidney cancer that has spread beyond the kidney
- Are able to walk on a treadmill and meet certain physical parameters

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Have a screening period where you will have a series of tests that will test how well your heart and vascular system are working and how physically fit you are.

After the screening period, you will be randomized (like a flip of a coin) to either an exercise plan OR your usual activity.

While you are active on study, you will:
- Follow your activity plan for 12 weeks
- Have repeat testing of your heart and vascular system and physical fitness
- Have blood draws
- Have the option to participate in a 12-week home-based exercise program after you finish the plan for 12 weeks

You will only be involved in the study between 12 and 24 weeks. Your physician will work with you to find out how long you will get ipilimumab and nivolumab.

Study Details

Full Title
INTENSE: Ipilimumab and Nivolumab Combination Therapy: A Randomized Study of an Immediate versus Delayed Exercise InterveNtion with Functional Capacity and Quality of Life Evaluations in Subjects with Advanced or MEtastatic Renal Cell Carcinoma
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00082941
NCT:NCT03692338
Phase
Phase N/A
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698