Low-moderate Intensity Pedaling During Immunotherapy Administration

Study Overview
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Brief Summary
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The purpose of this study is to determine the feasibility pedaling using an under-the desk bike during immunotherapy infusions. Also, the study hopes to evaluate how pedaling impacts quality of life and treatment response biomarkers. Lastly, the study will evaluate the relationships between treatment response and muscle mass which is evaluated with computerized tomography (CT) scans.

Official Title
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Evaluating the Effects of Low-moderate Intensity Pedaling During Immunotherapy Administration on Immune Biomarkers and Quality of Life

Conditions
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Cancer of Skin, Cancer of Kidney, Cancer of Bladder, Exercise, Aerobic, Immunotherapy

Intervention / Treatment
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* Behavioral: Pedaling Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Minimum age of 18 Renal Cell Carcinoma, cutaneous malignancies (Melanoma, Merkel Cell Carcinoma or Squamous Cell CA) or bladder cancer. Planned intravenous immunotherapy treatment (Pembrolizumab, Nivolumab, or combinations as clinically indicated by standards of care). ECOG Performance Status of Grade 0-2 No uncontrolled cardiac disease Exclusion Criteria: ECOG Performance Status of Grade 3-5 Severe cardiac history or comorbidities (i.e. heart failure, clinically significant aortic stenosis, history of cardiac arrest, have a cardiac defibrillator, uncontrolled angina, uncontrolled arrhythmias, major heart surgery, stroke, or pulmonary embolus). Chest pain or severe shortness of breath at rest or with physical activity. Orthopedic impediments to exercise (i.e. joint immobility or lower extremity lymphedema). Limitations to sustained exercise (i.e. bone metastases in the femur neck). Severe arthritis (i.e. osteoarthritis or rheumatoid arthritis). Patients will be excluded from study if their immunotherapy treatment requires the use of sedating antihistamines prior to treatment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pedaling Group<br>During their 30 minute immunotherapy infusions, participants will pedal using a stationary cycle ergometer. Participants will be allowed to determine their pedaling intensity and cadence, however, will be encouraged to reach the established goal intensity level. A research personnel will monitor the patient's heart rate, blood pressure, and RPE at baseline and every 10 minutes throughout the pedaling session. Participants will also have treatment response biomarkers gathered at baseline and before and within 10 minutes of completing their first and fourth immunotherapy infusions. Lastly, participants will complete both a physical activity questionnaire and a quality of life questionnaire at baseline and following their fourth treatment. | Behavioral: Pedaling Group<br>* Participants will pedal at low-moderate intensity using a stationary pedal ergometer concurrent to their immunotherapy infusion (30 minutes).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Pedaling Concurrent to Immunotherapy Infusions | The number of completed pedaling sessions as well as the ability of patients to meet goal pedaling intensities will be evaluated. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life scores | Quality of life markers will be assessed using the Quality of Life Questionnaire - Core 30, at baseline and following their fourth immunotherapy treatment. | 12 weeks | 
| Treatment response biomarkers | Treatment response biomarkers (check point inhibitors, functional T and B cell subsets, pro and anti-inflammatory monocyte subsets, and soluble inflammatory mediators) will be drawn before and immediately following first and fourth immunotherapy treatments. All biomarkers are available as either part of the MILLIPLEX® MAP Human High-sensitivity T-cell Assay or the ProcartaPlex Human Immuno-Oncology Checkpoint Panel. All assays will be run according to the manufacturer's recommended protocols on a Luminex FlexMAP 3D system with concentrations calculated based on 7-point standard curves. | 12 weeks | 
| CT-derived sarcopenia rates | CT images will be gathered at the time of diagnosis and following completion of immunotherapy treatments. Patient's CT scans will be uploaded to a medical image analysis software (SliceOmatic), which allows for the evaluation of body composition, focusing on sarcopenia or muscle depletion. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sarcopenia, Quality of Life, Immunologic Markers