Combined Aerobic and Resistance Exercise Training in Metastatic Renal Cell Carcinoma

Study Overview
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Brief Summary
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The trial studies the effects of personalized home-based aerobic and resistance exercises on quality of life, changes in physical activity levels, and the change in inflammatory myokines with the exercise intervention in Interleukin 6 (IL-6), C-reactive Protein (CRP), Leptin, Transforming growth factor beta (TGF-beta), and Interferon (INF) gamma.

Official Title
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A Pilot Study of Combined Aerobic and Resistance Exercise Training in Metastatic Renal Cell Carcinoma

Conditions
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Renal Cell Carcinoma Metastatic

Intervention / Treatment
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* Other: Combined Aerobic and Resistance Exercise Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed diagnosis of RCC Patients being treated with standard of Programmed cell death protein 1 (anti-PD-1) or anti-PD-L1 immune-checkpoint inhibitor-containing standard of care regimen including patients who are about to start treatment or have been on treatment for a maximum of 4 weeks prior to signing consent Metastatic Measurable disease, as defined by RECIST 1.1 Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 with a life expectancy ≥ six months Physically able to enroll in the exercise program as determined by the treating medical oncologist and after review by Physical medicine and rehabilitation physicians at Johns Hopkins Adequate bone marrow reserve and organ function measured within 28 days prior to administration of study treatment with the following key parameters: Hematological: Absolute neutrophil count ≥ 1.5 × 109/L Platelets ≥ 100 × 109/L Hemoglobin≥ 9.0 g/dL Renal: Serum Creatinine ≤ 1.5 x the upper limit of normal (ULN) or Calculated Creatinine clearance ≥ 30mL/min Hepatic: Total bilirubin ≤ 1.5 x ULN (Patients with known Gilbert disease who have serum bilirubin level ≤ 3 x ULN may be enrolled) Serum Aspartate aminotransferase (AST) and serum Alanine aminotransferase (ALT) ≤ 2.5 x ULN (For patients with documented liver metastases AST and/or ALT ≤ 5 x ULN) Exclusion Criteria: The presence of bone metastasis in the spine, pelvis, and lower limbs Currently physically active or moderately active as determined by Leisure Score Index of Godin Leisure-Time Exercise Questionnaire (GSLTPAQ) History of underlying cardiovascular, respiratory, musculoskeletal disease or joint problems that preclude moderate physical activity Known underlying uncontrolled brain metastatic lesions requires steroids therapy and/or radiotherapy Major surgery within four weeks prior to enrollment. Radiotherapy for RCC 28 days prior to week 1 day 1

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive Care<br>Patients with metastatic renal cell carcinoma (RCC) who are receiving immune-checkpoint inhibitor therapy | Other: Combined Aerobic and Resistance Exercise Training<br>* Participants receive personalized exercise plan for home-based two days of aerobic exercises (20-30-minutes) and two days of resistance exercises per week for 12 weeks. After completion of study intervention, participants will be assessed at the of study visit at Week 24.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who adhere to the exercise intervention |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients screened compared to patients enrolled |  | 2 years | 
| Percentage of patients who remained in the study and didn't drop off the study after enrollment |  | 2 years | 
| Change in HRQoL as measured by FACT-G Questionnaire | There are 27 items in Functional Assessment of Cancer Therapy: General (FACT-G) questionnaire, and they are scored on a scale from 0 to 4; 0 being Not at All, and 4 being Very much. | Baseline, Week 4, Week 8, Week 12 and Week 24 | 
| The incidence of grade 3-5 toxicities as per CTCAE 5.0 |  | 2 years |