Clinical trial · Interventional
Combined Aerobic and Resistance Exercise Training in Metastatic Renal Cell Carcinoma
A Pilot Study of Combined Aerobic and Resistance Exercise Training in Metastatic Renal Cell Carcinoma
NCT05103722CI-TRIAL-00075720terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study terminated due to lack of funding
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combined Aerobic and Resistance Exercise Training | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive Care
- description
- Patients with metastatic renal cell carcinoma (RCC) who are receiving immune-checkpoint inhibitor therapy
- interventionNames
- Other: Combined Aerobic and Resistance Exercise Training
Primary outcomes (1)
- measure
- Number of participants who adhere to the exercise intervention
- timeFrame
- 2 years
Secondary outcomes (4)
- measure
- Percentage of patients screened compared to patients enrolled
- timeFrame
- 2 years
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.