NCT05103722TerminatedNot Applicable
A Pilot Study of Combined Aerobic and Resistance Exercise Training in Metastatic Renal Cell Carcinoma
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 site in 1 country2 target enrollmentStarted: February 17, 2022Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Number of participants who adhere to the exercise intervention
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Serum Creatinine ≤ 1.5 x the upper limit of normal (ULN) or Calculated Creatinine clearance ≥ 30mL/min
- •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
Arms & Interventions
Supportive Care
Experimental
Patients with metastatic renal cell carcinoma (RCC) who are receiving immune-checkpoint inhibitor therapy
Intervention: Combined Aerobic and Resistance Exercise Training (Other)
Outcomes
Primary Outcomes
Number of participants who adhere to the exercise intervention
Time Frame: 2 years
Secondary Outcomes
- The incidence of grade 3-5 toxicities as per CTCAE 5.0(2 years)
- Change in HRQoL as measured by FACT-G Questionnaire(Baseline, Week 4, Week 8, Week 12 and Week 24)
- Percentage of patients who remained in the study and didn't drop off the study after enrollment(2 years)
- Percentage of patients screened compared to patients enrolled(2 years)
Investigators
Study Sites (1)
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