Combined Aerobic and Resistance Exercise Training in Metastatic Renal Cell Carcinoma

Johns Hopkins Medicine

Status: Terminated

Conditions: Renal Cell Carcinoma Metastatic

Treatments: Other: Combined Aerobic and Resistance Exercise Training

Study type: Interventional

Funder types: Other

Identifiers

NCT05103722

IRB00292763 (Other Identifier)

J2174

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Supportive Care

Experimental group

Description:

Patients with metastatic renal cell carcinoma (RCC) who are receiving immune-checkpoint inhibitor therapy

Treatment:

Other: Combined Aerobic and Resistance Exercise Training