Combined Aerobic and Resistance Exercise Training in Meta... | NCT05103722

Studies
Combined Aerobic and Resistance Exercise Training in Metastatic Renal Cell Carcinoma

NCT05103722

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Status

Terminated

Last Update Posted

Apr 4, 2024Actual

Enrollment

2Actual

Phase

Not Applicable

Conditions

Renal Cell Carcinoma Metastatic

Interventions

Combined Aerobic and Resistance Exercise Training

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
IRB00292763	Other Identifier	JHU IRB

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study terminated due to lack of funding

Expanded Access Info

Start Date

Feb 17, 2022Actual

Primary Completion Date

Apr 1, 2024Actual

Completion Date

Apr 1, 2024Actual

First Submitted Date

Oct 21, 2021

First Submission Date that Met QC Criteria

Oct 21, 2021

First Posted Date

Nov 2, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2024

Last Update Posted Date

Apr 4, 2024Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Measure	Description	Time Frame
Number of participants who adhere to the exercise intervention		2 years

Measure	Description	Time Frame
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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided