Clinical trial NCT05103722: Combined Aerobic and Resistance Exercise Training in Metastatic Renal Cell Carcinoma
Official title: A Pilot Study of Combined Aerobic and Resistance Exercise Training in Metastatic Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Renal Cell Carcinoma Metastatic
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants who adhere to the exercise intervention
timeFrame: 2 years
Secondary outcomes:
measure: Percentage of patients screened compared to patients enrolled
timeFrame: 2 years
measure: Percentage of patients who remained in the study and didn't drop off the study after enrollment
timeFrame: 2 years
measure: Change in HRQoL as measured by FACT-G Questionnaire
timeFrame: Baseline, Week 4, Week 8, Week 12 and Week 24
measure: The incidence of grade 3-5 toxicities as per CTCAE 5.0
timeFrame: 2 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University/Sidney Kimmel Cancer Center
state: Maryland
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Yasser Ged, MD
role: PRINCIPAL_INVESTIGATOR
References: