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Combined Aerobic and Resistance Exercise Training in Metastatic Renal Cell Carcinoma

Primary Purpose

Renal Cell Carcinoma Metastatic

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Combined Aerobic and Resistance Exercise Training

About this trial

This is an interventional supportive care trial for Renal Cell Carcinoma Metastatic

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Johns Hopkins University/Sidney Kimmel Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive Care

Arm Description

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

Outcomes

Primary Outcome Measures

Number of participants who adhere to the exercise intervention

Secondary Outcome Measures

Percentage of patients screened compared to patients enrolled

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

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".

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

Full Information

NCT ID

NCT05103722

First Posted

October 21, 2021

Last Updated

April 20, 2023

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

1. Study Identification

Unique Protocol Identification Number

NCT05103722

Brief Title

Combined Aerobic and Resistance Exercise Training in Metastatic Renal Cell Carcinoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 17, 2022 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Cell Carcinoma Metastatic

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Supportive Care

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Combined Aerobic and Resistance Exercise Training

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of participants who adhere to the exercise intervention

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Percentage of patients screened compared to patients enrolled

Time Frame

2 years

Title

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

Time Frame

2 years

Title

Change in HRQoL as measured by FACT-G Questionnaire

Description

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

Title

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

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yasser Ged, MD

Phone

410-955-8893

yged1@jhmi.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Yelena Milman, MA

Phone

410-955-1865

ymilman1@jhmi.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yasser Ged, MD

Organizational Affiliation

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins University/Sidney Kimmel Cancer Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yasser Ged, MD

Phone

410-955-8893

yed1@jhmi.edu

First Name & Middle Initial & Last Name & Degree

Yelena Milman, MA

Phone

410-955-1865

ymilman1@jhmi.edu

First Name & Middle Initial & Last Name & Degree

Yasser Ged, MD

12. IPD Sharing Statement

Plan to Share IPD

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Combined Aerobic and Resistance Exercise Training in Metastatic Renal Cell Carcinoma

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