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Combined Aerobic and Resistance Exercise Training in Metastatic Renal Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05103722
Recruitment Status : Recruiting
First Posted : November 2, 2021
Last Update Posted : April 24, 2023
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Description
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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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Metastatic Other: Combined Aerobic and Resistance Exercise Training Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Study of Combined Aerobic and Resistance Exercise Training in Metastatic Renal Cell Carcinoma
Actual Study Start Date : February 17, 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Supportive Care
Patients with metastatic renal cell carcinoma (RCC) who are receiving immune-checkpoint inhibitor therapy
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants who adhere to the exercise intervention [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Percentage of patients screened compared to patients enrolled [ Time Frame: 2 years ]
  2. Percentage of patients who remained in the study and didn't drop off the study after enrollment [ Time Frame: 2 years ]
  3. Change in HRQoL as measured by FACT-G Questionnaire [ Time Frame: 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".

  4. The incidence of grade 3-5 toxicities as per CTCAE 5.0 [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05103722


Contacts
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Contact: Yasser Ged, MD 410-955-8893 yged1@jhmi.edu
Contact: Yelena Milman, MA 410-955-1865 ymilman1@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Yasser Ged, MD    410-955-8893    yed1@jhmi.edu   
Contact: Yelena Milman, MA    410-955-1865    ymilman1@jhmi.edu   
Principal Investigator: Yasser Ged, MD         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Investigators
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Principal Investigator: Yasser Ged, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
More Information
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT05103722    
Other Study ID Numbers: J2174
IRB00292763 ( Other Identifier: JHU IRB )
First Posted: November 2, 2021    Key Record Dates
Last Update Posted: April 24, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
 Urogenital Neoplasms
Neoplasms by Site
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases