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TerminatedNCT05103722Updated Apr 4, 2024

Combined Aerobic and Resistance Exercise Training in Metastatic Renal Cell Carcinoma

An interventional study of Combined Aerobic and Resistance Exercise Training in Renal Cell Carcinoma Metastatic, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Terminated at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-04-04.

Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Not applicable, Interventional, and Supportive care

Why this study was terminated
Study terminated due to lack of funding
Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Not applicable
Ages
18 Years to 99 Years
Sex
All
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Study 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.

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Conditions studied

  • Renal Cell Carcinoma Metastatic
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In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 2 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is the lead sponsor of 572 studies on the registry; 73 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 67 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    Supportive Care

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

    Other: Combined Aerobic and Resistance Exercise Training

Interventions

  • OtherCombined 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.

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What researchers measure

Primary outcomes

  1. Number of participants who adhere to the exercise intervention

    Time frame: 2 years

Secondary outcomes

  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

    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".

    Time frame: Baseline, Week 4, Week 8, Week 12 and Week 24

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

    Time frame: 2 years

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Study locations

1 site
  • Johns Hopkins University/Sidney Kimmel Cancer Center
    Baltimore, Maryland 21287, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05103722
Lead sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Responsible party
Sponsor
First posted
Nov 2, 2021
Start date
Feb 17, 2022
Primary completion
Apr 1, 2024
Completion
Apr 1, 2024
Last update
Apr 4, 2024

Study contacts

Yasser Ged, MD
principal investigator · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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