Immunotherapy Clinical Trial
Official title:
Evaluating the Effects of Low-moderate Intensity Pedaling During Immunotherapy Administration on Immune Biomarkers and Quality of Life
NCT number | NCT04127318 |
Other study ID # | 19071102 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | January 31, 2020 |
Est. completion date | October 2020 |
Verified date | September 2022 |
Source | Rush University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 2020 |
Est. primary completion date | October 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Rush University Medical Center | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Rush University Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 |
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