Low-moderate Intensity Pedaling During Immunotherapy Administration

Rush

Status: Withdrawn

Conditions: Immunotherapy; Cancer of Kidney; Exercise, Aerobic; Cancer of Bladder; Cancer of Skin

Treatments: Behavioral: Pedaling Group

Study type: Interventional

Funder types: Other

Identifiers

NCT04127318

19071102

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Pedaling Group

Experimental group

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.

Treatment:

Behavioral: Pedaling Group