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Combined Aerobic and Resistance Exercise Training in Metastatic Renal Cell Carcinoma

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)
Overall Status
Recruiting
CT.gov ID
NCT05103722
Collaborator
(none)
16
Enrollment
1
Location
1
Arm
21.4
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Combined Aerobic and Resistance Exercise Training
 N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Feb 17, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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

Primary Outcome Measures

  1. Number of participants who adhere to the exercise intervention [2 years]

Secondary Outcome Measures

  1. Percentage of patients screened compared to patients enrolled [2 years]

  2. Percentage of patients who remained in the study and didn't drop off the study after enrollment [2 years]

  3. Change in HRQoL as measured by FACT-G Questionnaire [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 [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
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:

  • 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

Locations

Site City State Country Postal Code
1 Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland United States 21287

Sponsors and Collaborators

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Investigators

  • Principal Investigator: Yasser Ged, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier:
NCT05103722
Other Study ID Numbers:
  • J2174
  • IRB00292763
First Posted:
Nov 2, 2021
Last Update Posted:
Mar 29, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell

Study Results

No Results Posted as of Mar 29, 2022