Renal Cell CarcinomaPhase 3NCT00869011
Exercise for Patients With Renal Cell Cancer Receiving Sunitinib
A Phase 3 study testing Endurance exercise in people with Renal Cell Carcinoma, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
In this randomized, controlled trial the investigators evaluate the effects of an exercise program lasting for 12 weeks on the physical performance, the cardiovascular function (24h blood pressure, rest blood pressure and hear function) and the fatigue and mood of patients with renal cell carcinoma undergoing a… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- Endurance exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2009to Jun 2011
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 75 years
- Understanding of written German
- Treatment with Sunitinib
- Ability to walk
Who cannot join
- Cardiovascular, pulmonary or osteoarticular disease which can be aggravated by exercise
- BMI < 18 or > 30
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30
Berlin, State of Berlin, 12200
Fernando C. Dimeo, MD, +493084452098, fernando.dimeo@charite.de
Fernando C. Dimeo, MD
About this study
Official title: Effects of Physical Activity on the Endothelial and Cardiac Function of Patients With Renal Cell Carcinoma Receiving a Thyrosine Kinase Inhibitor (Sunitinib)
In this randomized, controlled trial the investigators evaluate the effects of an exercise program lasting for 12 weeks on the physical performance, the cardiovascular function (24h blood pressure, rest blood pressure and hear function) and the fatigue and mood of patients with renal cell carcinoma undergoing a therapy with Sunitinib.
- Conditions
- Renal Cell Carcinoma
- Being tested
- Endurance exercise
- Keywords
- Cancer, renal cell carcinoma, fatigue, exercise
- Medical subject headings
- Carcinoma, Renal Cell, Neoplasms, Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endurance exerciseOther
Endurance exercise, 3 times weekly for 35-45 minutes, 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Exercise Receives: Other: Endurance exercise |
| 2 | No intervention | No structured exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Measured: 12 weeks
Secondary outcomes (3)
VO2max
Measured: 12 weeks
Systolic and diastolic blood pressure (24 h)
Measured: 12 weeks
Depression score
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2009 (estimated)
- Study startDec 2009
- Primary completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00869011
- Sponsor's protocol ID
- SUIR8687
- Status last verified
- Dec 2009
- First submitted
- 23 Mar 2009
- Last updated
- 23 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Activity on the Endothelial and Cardiac Function of Patients With Renal Cell Carcinoma Receiving a Thyrosine Kinase Inhibitor (Sunitinib)
- ClinicalTrials.gov ID
- NCT00869011
- Acronym / sponsor ID
- SUIR8687
- Conditions
- Renal Cell Carcinoma
- Keywords
- Cancer, renal cell carcinoma, fatigue, exercise
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Dec 2009
- Primary completion
- Jun 2011 (estimated)
- First posted
- 25 Mar 2009 (estimated)
- 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.
In this randomized, controlled trial the investigators evaluate the effects of an exercise program lasting for 12 weeks on the physical performance, the cardiovascular function (24h blood pressure, rest blood pressure and hear function) and the fatigue and mood of patients with renal cell carcinoma undergoing a therapy with Sunitinib.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Endurance exerciseExercise |
| 2 | No intervention | –No structured exercise program |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 to 75 years
- Understanding of written German
- Treatment with Sunitinib
- Ability to walk
Key exclusion criteria (2 listed)
- Cardiovascular, pulmonary or osteoarticular disease which can be aggravated by exercise
- BMI < 18 or > 30
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 |
|---|---|---|
| Endurance exerciseEndurance exercise, 3 times weekly for 35-45 minutes, 12 weeks. | Other | 1 |
Primary outcome
Fatigue
Time frame: 12 weeks
3 secondary outcomes
VO2max
Time frame: 12 weeks
Systolic and diastolic blood pressure (24 h)
Time frame: 12 weeks
Depression score
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2009.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Endurance exercise in people with Renal Cell Carcinoma, run by Charite University, Berlin, Germany at 1 site in Germany.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Dec 2009. 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 Germany. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernando C. Dimeo, MD (+493084452098, fernando.dimeo@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: 12 weeks). 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 23 Dec 2009.