Renal Cell Carcinoma MetastaticNCT05103722
Combined Aerobic and Resistance Exercise Training in Metastatic Renal Cell Carcinoma
A study testing Combined Aerobic and Resistance Exercise Training in people with Renal Cell Carcinoma Metastatic, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Renal Cell Carcinoma Metastatic
- What is being tested?
- Combined Aerobic and Resistance Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2022to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
About this study
Official title: A Pilot Study of Combined Aerobic and Resistance Exercise Training in Metastatic Renal Cell Carcinoma
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.
- Conditions
- Renal Cell Carcinoma Metastatic
- Being tested
- Combined Aerobic and Resistance Exercise Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Aerobic and Resistance Exercise TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care | Experimental | Patients with metastatic renal cell carcinoma (RCC) who are receiving immune-checkpoint inhibitor therapy Receives: Other: Combined Aerobic and Resistance Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who adhere to the exercise intervention
Measured: 2 years
Secondary outcomes (4)
Percentage of patients screened compared to patients enrolled
Measured: 2 years
Percentage of patients who remained in the study and didn't drop off the study after enrollment
Measured: 2 years
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".
Measured: Baseline, Week 4, Week 8, Week 12 and Week 24
The incidence of grade 3-5 toxicities as per CTCAE 5.0
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start17 Feb 2022
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Why it stopped: Study terminated due to lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell Carcinoma MetastaticStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yasser Ged, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103722
- Sponsor's protocol ID
- J2174
- Other IDs
- IRB00292763
- Status last verified
- Apr 2024
- First submitted
- 21 Oct 2021
- Last updated
- 4 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Combined Aerobic and Resistance Exercise Training in Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05103722
- Acronym / sponsor ID
- J2174
- Conditions
- Renal Cell Carcinoma Metastatic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to lack of funding
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 2 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care | Experimental | Other: Combined Aerobic and Resistance Exercise TrainingPatients with metastatic renal cell carcinoma (RCC) who are receiving immune-checkpoint inhibitor therapy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined Aerobic and Resistance Exercise TrainingParticipants 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. | Other | Supportive Care |
Primary outcome
Number of participants who adhere to the exercise intervention
Time frame: 2 years
4 secondary outcomes
Percentage of patients screened compared to patients enrolled
Time frame: 2 years
Percentage of patients who remained in the study and didn't drop off the study after enrollment
Time frame: 2 years
Change in HRQoL as measured by FACT-G Questionnaire
Time frame: Baseline, Week 4, Week 8, Week 12 and Week 24
The incidence of grade 3-5 toxicities as per CTCAE 5.0
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Study terminated due to lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasser Ged, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Aerobic and Resistance Exercise Training in people with Renal Cell Carcinoma Metastatic, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study terminated due to lack of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who adhere to the exercise intervention (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.