Low-moderate Intensity Pedaling During Immunotherapy Administration

Rush University Medical Center

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

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

Interventions

Pedaling GroupBEHAVIORAL

Participants will pedal at low-moderate intensity using a stationary pedal ergometer concurrent to their immunotherapy infusion (30 minutes).

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Rush University Medical Center

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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.

Time frame: 12 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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