Combined Aerobic and Resistance Exercise Training in Metastatic Renal Cell Carcinoma

  • STATUS
    Recruiting
  • End date
    Dec 18, 2023
  • participants needed
    16
  • sponsor
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Updated on 18 April 2022

Summary

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.

Details
Condition Renal Cell Carcinoma Metastatic
Treatment Combined Aerobic and Resistance Exercise Training
Clinical Study IdentifierNCT05103722
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last Modified on18 April 2022

Eligibility

Yes No Not Sure

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
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