Combined Aerobic and Resistance Exercise Training in Metastatic Renal Cell Carcinoma

NCT05103722 | Terminated

• 2 other identifiers: J2174IRB00292763
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of participants who adhere to the exercise intervention

  2 years

Secondary Outcomes (4)

• Percentage of patients screened compared to patients enrolled

  2 years

• Percentage of patients who remained in the study and didn't drop off the study after enrollment

  2 years

• Change in HRQoL as measured by FACT-G Questionnaire

  Baseline, Week 4, Week 8, Week 12 and Week 24

• The incidence of grade 3-5 toxicities as per CTCAE 5.0

  2 years

Study Arms (1)

Supportive Care

EXPERIMENTAL

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

Other: Combined Aerobic and Resistance Exercise Training

Interventions

Combined Aerobic and Resistance Exercise Training 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.

Supportive Care

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States

Location

Study Officials

• Yasser Ged, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 2, 2021
• Study Start: February 17, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)