Low-moderate Intensity Pedaling During Immunotherapy Administration

NCT04127318 | Withdrawn

• 1 other identifier: 19071102
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Sarcopenia; Quality of Life; Immunologic Markers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Quality of life scores

  12 weeks

• Treatment response biomarkers

  12 weeks

• CT-derived sarcopenia rates

  12 weeks

Study Arms (1)

Pedaling Group

EXPERIMENTAL

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.

Behavioral: Pedaling Group

Interventions

Pedaling Group BEHAVIORAL

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

Pedaling Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Skin Neoplasms; Kidney Neoplasms; Urinary Bladder Neoplasms; Motor Activity; Sarcopenia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Urinary Bladder Diseases; Behavior; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Timothy M Kuzel, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: October 15, 2019
• Study Start: January 31, 2020
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: September 23, 2022

Record last verified: 2022-09

Locations

US (1)