Back to resultsLow-moderate Intensity Pedaling During Immunotherapy Administration
Primary Purpose
Cancer of Skin, Cancer of Kidney, Cancer of Bladder
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pedaling Group
Sponsored by
About this trial
This is an interventional treatment trial for Cancer of Skin focused on measuring Sarcopenia, Quality of Life, Immunologic Markers
Eligibility Criteria
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.
Sites / Locations
- Rush University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pedaling Group
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04127318
First Posted
September 26, 2019
Last Updated
September 21, 2022
Sponsor
Rush University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04127318
Brief Title
Low-moderate Intensity Pedaling During Immunotherapy Administration
Official Title
Evaluating the Effects of Low-moderate Intensity Pedaling During Immunotherapy Administration on Immune Biomarkers and Quality of Life
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Withdrawn
Why Stopped
lack of resources
Study Start Date
January 31, 2020 (Actual)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Skin, Cancer of Kidney, Cancer of Bladder, Exercise, Aerobic, Immunotherapy
Keywords
Sarcopenia, Quality of Life, Immunologic Markers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pedaling Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Pedaling Group
Intervention Description
Participants will pedal at low-moderate intensity using a stationary pedal ergometer concurrent to their immunotherapy infusion (30 minutes).
Primary Outcome Measure Information:
Title
Feasibility of Pedaling Concurrent to Immunotherapy Infusions
Description
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 Outcome Measure Information:
Title
Quality of life scores
Description
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
Title
Treatment response biomarkers
Description
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
Title
CT-derived sarcopenia rates
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy M Kuzel, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Low-moderate Intensity Pedaling During Immunotherapy Administration
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