Status:
WITHDRAWN
Low-moderate Intensity Pedaling During Immunotherapy Administration
Lead Sponsor:
Rush University Medical Center
Conditions:
Cancer of Skin
Cancer of Kidney
Eligibility:
All Genders
18+ years
Phase:
NA
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04127318
Start Date
January 31 2020
End Date
October 1 2020
Last Update
September 23 2022
Active Locations (1)
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1
Rush University Medical Center
Chicago, Illinois, United States, 60612