Combined Aerobic and Resistance Exercise Training in Metastatic Renal Cell Carcinoma

Not Applicable

Terminated

• Conditions: Renal Cell Carcinoma Metastatic
• Interventions: Other: Combined Aerobic and Resistance Exercise Training

• Registration Number: NCT05103722
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-21
• Study First Submitted QC: 2021-10-21
• Study First Posted: 2021-11-02
• Study Start: 2022-02-17
• Status Verified: 2024-04
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-01
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive Care	Combined Aerobic and Resistance Exercise Training	Patients with metastatic renal cell carcinoma (RCC) who are receiving immune-checkpoint inhibitor therapy

Primary Outcome Measures

Name	Time	Method
Number of participants who adhere to the exercise intervention	2 years

Secondary Outcome Measures

Name	Time	Method
Change in HRQoL as measured by FACT-G Questionnaire	Baseline, Week 4, Week 8, Week 12 and Week 24	There are 27 items in Functional Assessment of Cancer Therapy: General (FACT-G) questionnaire, and they are scored on a scale from 0 to 4; 0 being "Not at All", and 4 being "Very much".
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
The incidence of grade 3-5 toxicities as per CTCAE 5.0	2 years

Trial Locations

Locations (1)

Johns Hopkins University/Sidney Kimmel Cancer Center; 🇺🇸 Baltimore, Maryland, United States