Combined Aerobic and Resistance Exercise Training in Metastatic Renal Cell Carcinoma

Renal Cell Carcinoma Metastatic Clinical Trial

Official title:

A Pilot Study of Combined Aerobic and Resistance Exercise Training in Metastatic Renal Cell Carcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05103722
• Other study ID #: J2174
• Secondary ID: IRB00292763
• Status: Terminated
• Phase: N/A
• Start date: February 17, 2022
• Est. completion date: April 1, 2024

Study information

• Verified date: April 2024
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma Metastatic

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins University/Sidney Kimmel Cancer Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who adhere to the exercise intervention		2 years
Secondary	Percentage of patients screened compared to patients enrolled		2 years
Secondary	Percentage of patients who remained in the study and didn't drop off the study after enrollment		2 years
Secondary	Change in HRQoL as measured by FACT-G Questionnaire	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".	Baseline, Week 4, Week 8, Week 12 and Week 24
Secondary	The incidence of grade 3-5 toxicities as per CTCAE 5.0		2 years