Cancer of Bladder, Cancer of Kidney, Cancer of Skin, Exercise, Aerobic, Immunotherapy
Conditions
Keywords
Sarcopenia, Quality of Life, Immunologic Markers
Brief summary
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.
Interventions
BEHAVIORALPedaling Group
Participants will pedal at low-moderate intensity using a stationary pedal ergometer concurrent to their immunotherapy infusion (30 minutes).
Sponsors
Rush University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Pedaling Concurrent to Immunotherapy Infusions | 12 weeks | The number of completed pedaling sessions as well as the ability of patients to meet goal pedaling intensities will be evaluated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life scores | 12 weeks | Quality of life markers will be assessed using the Quality of Life Questionnaire - Core 30, at baseline and following their fourth immunotherapy treatment. |
| Treatment response biomarkers | 12 weeks | 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. |
| CT-derived sarcopenia rates | 12 weeks | 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. |
Countries
United States
Outcome results
None listed