Prostate CancerNCT01676480
The Effect of Endurance Training on Body Composition and Insulin Sensitivity in Prostate Cancer Patients Receiving Androgen Deprivation Therapy
A study testing Endurance training in people with Prostate Cancer, run by Inge Holm at 1 site in Denmark.
Trial summary
The purpose of the present study is to investigate if endurance training can be used as a therapeutic action against the adverse metabolic disturbances and unfavourable changes in body composition that accompany the androgen deprivation therapy (ADT) treatment in prostate cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Endurance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2009to Sep 2011
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Prostate cancer patients receiving ADT for at least 3 months
- Healthy age and BMI matched controls
Who cannot join
- severe cardiovascular disease
- severe arthritis
- severe neuropathy
- severe hypertension
- therapy with antidiabetic agents
- VO2max > 30.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Centre of Inflammation and Metabolism, Rigshospitalet
Copenhagen, 2100
About this study
Official title: The Effect of Endurance Training on Body Composition and Insulin Sensitivity in Prostate Cancer Patients Receiving ADT
The purpose of the present study is to investigate if endurance training can be used as a therapeutic action against the adverse metabolic disturbances and unfavourable changes in body composition that accompany the androgen deprivation therapy (ADT) treatment in prostate cancer patients.
- Conditions
- Prostate Cancer
- Being tested
- Endurance training
- Keywords
- Prostate cancer, ADT, Endurance training
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endurance trainingBehavioural
12 weeks of endurance training 3 times per week
| Study group | Role | What they receive |
|---|---|---|
| ADT group | Experimental | Not described Receives: Behavioral: Endurance training |
| Control group | Experimental | Not described Receives: Behavioral: Endurance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body composition and insulin sensitivity in response to training
Measured: Body composition and insulin sensitivity are measured at baseline and after 12 weeks of endurance training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2012 (estimated)
- Study startSep 2009
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inge Holm
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev Hospital
- Responsible party
- Sponsor-investigator, Inge Holm, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Bente K Pedersen, Study director, Centre of Inflammation and Metabolism, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01676480
- Sponsor's protocol ID
- H-4-2009-102
- Status last verified
- Sep 2012
- First submitted
- 10 Jan 2012
- Last updated
- 5 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Endurance Training on Body Composition and Insulin Sensitivity in Prostate Cancer Patients Receiving ADT
- ClinicalTrials.gov ID
- NCT01676480
- Acronym / sponsor ID
- H-4-2009-102
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, ADT, Endurance training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Inge HolmUniversity, hospital or other
- Collaborators
- Herlev Hospital
- Study start
- Sep 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 31 Aug 2012 (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.
The purpose of the present study is to investigate if endurance training can be used as a therapeutic action against the adverse metabolic disturbances and unfavourable changes in body composition that accompany the androgen deprivation therapy (ADT) treatment in prostate cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADT group | Experimental | Behavioral: Endurance training |
| Control group | Experimental | Behavioral: Endurance training |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Prostate cancer patients receiving ADT for at least 3 months
- Healthy age and BMI matched controls
Key exclusion criteria (6 listed)
- severe cardiovascular disease
- severe arthritis
- severe neuropathy
- severe hypertension
- therapy with antidiabetic agents
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 training12 weeks of endurance training 3 times per week | Behavioural | ADT group, Control group |
Primary outcome
Changes in body composition and insulin sensitivity in response to training
Time frame: Body composition and insulin sensitivity are measured at baseline and after 12 weeks of endurance training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2012.
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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.
Bente K Pedersen study director
Centre of Inflammation and Metabolism, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endurance training in people with Prostate Cancer, run by Inge Holm at 1 site in Denmark.
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 2 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: finished, as of the sponsor's last update on 5 Sep 2012. 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 Denmark. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in body composition and insulin sensitivity in response to training (time frame: Body composition and insulin sensitivity are measured at baseline and after 12 weeks of endurance training). 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 5 Sep 2012.