Combined Aerobic and Resistance Exercise Training in Metastatic Renal Cell Carcinoma

NCT ID: NCT05103722

Last Updated: 2024-04-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-17
• Study Completion Date: 2024-04-01

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.

Conditions

Renal Cell Carcinoma Metastatic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Supportive Care

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

Group Type: EXPERIMENTAL

Combined Aerobic and Resistance Exercise Training

Intervention Type: OTHER

Participants receive personalized exercise plan for home-based two days of aerobic exercises (20-30-minutes) and two days of resistance exercises per week for 12 weeks. After completion of study intervention, participants will be assessed at the of study visit at Week 24.

Interventions

Combined Aerobic and Resistance Exercise Training

Participants receive personalized exercise plan for home-based two days of aerobic exercises (20-30-minutes) and two days of resistance exercises per week for 12 weeks. After completion of study intervention, participants will be assessed at the of study visit at Week 24.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yasser Ged, MD

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00292763

Identifier Type: OTHER

Identifier Source: secondary_id

J2174

Identifier Type: -

Identifier Source: org_study_id