Low-moderate Intensity Pedaling During Immunotherapy Administration

Immunotherapy Clinical Trial

Official title:

Evaluating the Effects of Low-moderate Intensity Pedaling During Immunotherapy Administration on Immune Biomarkers and Quality of Life

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04127318
• Other study ID #: 19071102
• Status: Withdrawn
• Phase: N/A
• Start date: January 31, 2020
• Est. completion date: October 2020

Study information

• Verified date: September 2022
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn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.

Related Conditions & MeSH terms

• Cancer of Bladder
• Cancer of Kidney
• Cancer of Skin
• Carcinoma, Renal Cell
• Exercise, Aerobic
• Immunotherapy
• Kidney Neoplasms
• Skin Neoplasms
• Urinary Bladder Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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